CLASS II Device recall · Reported 20 Apr 2016 · FDA Enforcement Report

Catalog Number: 9001300 Neuro-spine Surgical Pack Used by medical recalled

Customed is recalling Catalog Number: 9001300 Neuro-spine Surgical Pack Used by medical, distributed in Puerto Rico. The recall was initiated on 7 Jan 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLOTS: SL15202 (150619129) 30-JUN-16 SL15209 (150619381) 31-JUL-16 SL15215 (150619381) 31-JUL-16 SL15265 (150919830) 30-SEP-16 SL15265 (150920072) 30-SEP-16
Quantity recalled81

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1421-2016
FDA event ID
72992
Recalling firm
Customed, Fajardo, PR
Classification
Class II
Status
Terminated
Recall initiated
7 Jan 2016
FDA classified
14 Apr 2016
Reported
20 Apr 2016
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Sterility
Device type
Spinal Implants

Timeline

7 Jan 2016Recall initiated by company
14 Apr 2016Classified by FDA+98 days
20 Apr 2016Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Catalog Number: 9001300 NEURO-SPINE SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Where it was distributed

Distributed only in Puerto Rico.

Puerto Rico

Questions about this recall

Why was it recalled?

Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

Which lots are affected?

LOTS: SL15202 (150619129) 30-JUN-16 SL15209 (150619381) 31-JUL-16 SL15215 (150619381) 31-JUL-16 SL15265 (150919830) 30-SEP-16 SL15265 (150920072) 30-SEP-16

Where was it sold?

Distributed only in Puerto Rico.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

99 other products · FDA event 72992

This product is part of a recall event; the main page for the event is Catalog Number: 9003190 Surg Gown SMS Ammi IV Full Used by medical recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IICatalog Number: 9003190 Surg Gown SMS Ammi IV Full Used by medical recalledCustomedSterilityPR
CLASS IICatalog Number: 9002615 Extremity Surgical Pack Used recalledCustomedSterilityPR
CLASS IICatalog Number: 9001482 ENT Surgical Pack Used by medical staff recalledCustomedSterilityPR
CLASS IICatalog Number: 900110 Tracheostomy Care KIT With Trach Tube Holder recalledCustomedSterilityPR
CLASS IICatalog Number: 9001408 Umbilical Vessel Catheter KIT Used recalledCustomedSterilityPR
CLASS IICatalog Number: 900582 Utility Drape With Tape, SMS Used by medical recalledCustomedSterilityPR
CLASS IICatalog Number: 900946 Strabismus Surgical Pack Used recalledCustomedSterilityPR
CLASS IICatalog Number: 9002830 Orthopedic Surgical Pack Used by medical recalledCustomedSterilityPR
CLASS IICatalog Number: 900921A C-section Surgical Pack Used recalledCustomedSterilityPR
CLASS IICatalog Number: 9001538 Dressing Change Tray Used recalled by CustomedCustomedSterilityPR
CLASS IICatalog Number: 900036 Laparotomy Surgical Pack Used recalledCustomedSterilityPR
CLASS IICatalog Number: 900522 Surgical Gown SMS Poly-reinforced, Raglan recalledCustomedSterilityPR
CLASS IICatalog Number: 900576A Lap-cholecystectomy Surgical Pack Used recalledCustomedSterilityPR
CLASS IICatalog Number: 900028 Laparoscopy Surgical Pack recalled by CustomedCustomedSterilityPR
CLASS IICatalog Number: 9002618 Open Heart Surgical Pack Used by medical recalledCustomedSterilityPR
CLASS IICatalog Number: 900345 Basic Surgical Pack Used by medical staff recalledCustomedSterilityPR
CLASS IICatalog Number: 9002726 HIP AND Knee Replacement Surgical Pack Used recalledCustomedSterilityPR
CLASS IICatalog Number: 9002609 Arthoscopy Pack Used by medical staff recalledCustomedSterilityPR
CLASS IICatalog Number: 900020 Irrigation Tray With Irrigation Bulb Syringe recalledCustomedSterilityPR
CLASS IICatalog Number: 900782 Skin Staple Remover Sterile Used by medical recalledCustomedSterilityPR
CLASS IICatalog Number: 9001780 Ophthalmic Surgical Pack Used by medical recalledCustomedSterilityPR
CLASS IICatalog Number: 9002516 Laparotomy Surgical Pack Used by medical recalledCustomedSterilityPR
CLASS IICatalog Number: 9002167 Lithotomy Surgical Pack Used recalledCustomedSterilityPR
CLASS IICatalog Number: 9001091 Pery-gyn Surgical Pack Used by medical staff recalledCustomedSterilityPR
CLASS IICatalog Number: 9001456 Wound Management Tray Used by medical staff recalledCustomedSterilityPR
CLASS IICatalog Number: 9001139 Foley Catheter Tray 18 FR -5CC-2WAY Silicone recalledCustomedSterilityPR
CLASS IICatalog Number: 900063 Wound Closure Tray I Used by medical staff recalledCustomedSterilityPR
CLASS IICatalog Number: 9001771 Mayo Stand Cover Sterile Used by medical recalledCustomedSterilityPR
CLASS IICatalog Number: 9001521 Urology Surgical Pack Used by medical staff recalledCustomedSterilityPR
CLASS IICatalog Number: 900540 Wound Management Tray III Used by medical recalledCustomedSterilityPR
CLASS IICatalog Number: 900774 Incision AND Drainage Tray Used by medical recalledCustomedSterilityPR
CLASS IICatalog Number: 900012 OB Surgical Pack Used by medical staff recalledCustomedSterilityPR
CLASS IICatalog Number: 9001127 Foley Catheter Tray 16 FR-5CC- 2WAY Silicone recalledCustomedSterilityPR
CLASS IICatalog Number: 900410 Cesarean Section Surgical Pack Used recalledCustomedSterilityPR
CLASS IICatalog Number: 9001771 Mayo Stand Cover Sterile Used by medical recalledCustomedSterilityPR
CLASS IICatalog Number: 9002899 Cysto TUR Surgical Pack Used recalledCustomedSterilityPR
CLASS IICatalog Number: 900740A Arthroscopy Surgical Pack Used by medical recalledCustomedSterilityPR
CLASS IICatalog Number: 900982 Arthroscopy Surgical Pack Used by medical recalledCustomedSterilityPR
CLASS IICatalog Number: 9001202 Laminectomy PK Used by medical staff recalledCustomedSterilityPR
CLASS IICatalog Number: 900032 Universal Drainage Tray Used by medical staff recalledCustomedSterilityPR
CLASS IICatalog Number: 900486 Laparoscopy Surgical Pack Used by medical recalledCustomedSterilityPR
CLASS IICatalog Number: 9002259A Laparoscopy-colorectal Surgical recalledCustomedSterilityPR
CLASS IICatalog Number: 900176 Laparotomy Surgical Pack Used recalledCustomedSterilityPR
CLASS IICatalog Number: 9001294 Premium Cesarean Pack Used by medical staff recalledCustomedSterilityPR
CLASS IICatalog Number: 900996 Laparotomy Surgical Pack Used recalledCustomedSterilityPR
CLASS IICatalog Number: 9002224 Surgical Pack Used by medical staff recalledCustomedSterilityPR
CLASS IICatalog Number: 9001061 Peri-gyn Surgical Pack Used by medical staff recalledCustomedSterilityPR
CLASS IICatalog Number: 9001297 Premium Obstetrical Surgical Pack Used recalledCustomedSterilityPR
CLASS IICatalog Number: 900484 Laparoscopic Gynecology Surgical Pack Used recalledCustomedSterilityPR
CLASS IICatalog Number: 9002256 Neurosurgery Pack Used by medical staff recalledCustomedSterilityPR
CLASS IICatalog Number: 900281A Laparotomy Pack Used by medical staff recalledCustomedSterilityPR
CLASS IICatalog Number: 900521 Surgical Gown SMS Poly-reinforced, Raglan recalledCustomedSterilityPR
CLASS IICatalog Number: 9001765 Minor Laceration Tray Used by medical staff recalledCustomedSterilityPR
CLASS IICatalog Number: 900052 Minor Procedure Surgical Pack Used by medical recalledCustomedSterilityPR
CLASS IICatalog Number: 900474 Laparoscopy Surgical Pack Used by medical recalledCustomedSterilityPR
CLASS IICatalog Number: 9001496 D&C Laparoscopy Surgical Pack Used recalledCustomedSterilityPR
CLASS IICatalog Number: 900998 Cesarean Section Surgical Pack Used recalledCustomedSterilityPR
CLASS IICatalog Number: 9002123 Knee Arthroscopy Surgical Pack Used recalledCustomedSterilityPR
CLASS IICatalog Number: 9001966 Liver & Pancreas Surgery Used by medical recalledCustomedSterilityPR
CLASS IICatalog Number: 9001062 Arthroscopy Surgical Pack Used by medical recalledCustomedSterilityPR
CLASS IICatalog Number: 900080 Cystoscopy Surgical Pack Used recalledCustomedSterilityPR
CLASS IICatalog Number: 9002829 Basic Surg Pack Used by medical staff recalledCustomedSterilityPR
CLASS IICatalog Number: 9002766 Shoulder Pack Used by medical staff recalledCustomedSterilityPR
CLASS IICatalog Number: 9001460 Reyito Plus Urology Surgical Pack Used recalledCustomedSterilityPR
CLASS IICatalog Number: 900997 Peri-gyn Surgical Pack Used by medical staff recalledCustomedSterilityPR
CLASS IICatalog Number: 9001298 Premium Arthroscopy Pack Used by medical recalledCustomedSterilityPR
CLASS IICatalog Number: 9002511 Minor Surgical Pack Used by medical staff recalledCustomedSterilityPR
CLASS IICatalog Number: 900944 Cataract Surgical Pack Used by medical staff recalledCustomedSterilityPR
CLASS IICatalog Number: 900618A Laparoscopy-gyn Surgical Pack Used recalledCustomedSterilityPR
CLASS IICatalog Number: 9001402 Plastic Surgery Pack Used recalled by CustomedCustomedSterilityPR
CLASS IICatalog Number: 9002164 Femoral Surgical Pack Used by medical staff recalledCustomedSterilityPR
CLASS IICatalog Number: 900633 FAN Fold Sheet 44 X 58 Used by medical staff recalledCustomedSterilityPR
CLASS IICatalog Number: 900168 Labor & Delivery Surgical Pack Used recalledCustomedSterilityPR
CLASS IICatalog Number: 900164 Femoral Surgical Pack Used recalled by CustomedCustomedSterilityPR
CLASS IICatalog Number: 900796 Femoral Angiography Surgical Pack Used recalledCustomedSterilityPR
CLASS IICatalog Number: 900064 Wound Closure Tray II Used recalled by CustomedCustomedSterilityPR
CLASS IICatalog Number: 900419 Labor & Delivery Surgical Pack Used recalledCustomedSterilityPR
CLASS IICatalog Number: 9001154 Wound Management Tray Used by medical staff recalledCustomedSterilityPR
CLASS IICatalog Number: 900547 Basic Surgical Pack Used by medical staff recalledCustomedSterilityPR
CLASS IICatalog Number: 900741A Ortho-implant Surgical Pack Used by medical recalledCustomedSterilityPR
CLASS IICatalog Number: 900742A Carpal Tunel Large Surgical Pack Used recalledCustomedSterilityPR
CLASS IICatalog Number: 900278 Urethral Catheter Tray 14FR Used by medical recalledCustomedSterilityPR
CLASS IICatalog Number: 9001574 Leggins 30X42 W/7" Cuff Used recalledCustomedSterilityPR
CLASS IICatalog Number: 9002614 HIP AND Knee Replacement Surgical Pack Used recalledCustomedSterilityPR
CLASS IICatalog Number: 900450 Laparotomy Surgical Pack Used recalledCustomedSterilityPR
CLASS IICatalog Number: 900548A Pery-gyn Surgical Pack Used by medical staff recalledCustomedSterilityPR
CLASS IICatalog Number: 9001198 Wound Manage II Used by medical staff recalledCustomedSterilityPR
CLASS IICatalog Number: 900403 Cesarean Section Surgical Pack Used recalledCustomedSterilityPR
CLASS IICatalog Number: 900629 Sterile OR Cloth Towel Blue Used by medical recalledCustomedSterilityPR
CLASS IICatalog Number: 9002510 Urology Surgical Pack Used by medical staff recalledCustomedSterilityPR
CLASS IICatalog Number: 9002469 Basic Surgical Pack IV Used by medical staff recalledCustomedSterilityPR
CLASS IICatalog Number: 9002193 Shoulder Arthroscopy Surgical Pack Used recalledCustomedSterilityPR
CLASS IICatalog Number: 9001738 Urology Surgical Pack Used by medical staff recalledCustomedSterilityPR
CLASS IICatalog Number: 9001296 Premium Laparotomy Pack Used recalledCustomedSterilityPR
CLASS IICatalog Number: 900169 Universal Surgical Pack Used by medical staff recalledCustomedSterilityPR
CLASS IICatalog Number: 9001933 Ophtalmic Surgical Pack Used recalledCustomedSterilityPR
CLASS IICatalog Number: 900010 Suture Removal KIT Used by medical staff recalledCustomedSterilityPR
CLASS IICatalog Number: 9002940 Obstetrical Surgical Pack Used by medical recalledCustomedSterilityPR
CLASS IICatalog Number: 900277 Suction Catheter Tray 14FR With Sodium recalledCustomedSterilityPR

More recalls from Customed

All 682
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IICatalog Number: 900277 Suction Catheter Tray 14FR With Sodium recalledCustomedSterilityPR
DeviceCLASS IICatalog Number: 9002940 Obstetrical Surgical Pack Used by medical recalledCustomedSterilityPR
DeviceCLASS IICatalog Number: 900010 Suture Removal KIT Used by medical staff recalledCustomedSterilityPR
DeviceCLASS IICatalog Number: 9001933 Ophtalmic Surgical Pack Used recalledCustomedSterilityPR
DeviceCLASS IICatalog Number: 900169 Universal Surgical Pack Used by medical staff recalledCustomedSterilityPR

Other Spinal Implants recalls

All 1,157
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IINeuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalledAvid MedicalSterilityNationwide
DeviceCLASS IIHalyard medical convenience kits labeled as: ENT recalledAvid MedicalSterilityNationwide
DeviceCLASS IIHalyard medical convenience kits labeled as: A-P PACK recalledAvid MedicalSterilityNationwide
DeviceCLASS IIMedline medical convenience kits, labeled as recalledMedline IndustriesOtherNationwide
DeviceCLASS IIMedline medical convenience kits, labeled as recalledMedline IndustriesOtherNationwide