CLASS II Device recall · Reported 9 Sep 2015 · FDA Enforcement Report

Eent Pack I 10/CS Customed Used by medical staff to perform recalled

Customed is recalling Eent Pack I 10/CS Customed Used by medical staff to perform surgical procedures and, distributed in Puerto Rico. The recall was initiated on 10 Jul 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCode:9002498 Lots: 150116588 exp. 1/31/16 150116586 exp. 1/31/16 150116587 exp. 1/31/16
Quantity recalled10

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-2636-2015
FDA event ID
71721
Recalling firm
Customed, Fajardo, PR
Classification
Class II
Status
Terminated
Recall initiated
10 Jul 2015
FDA classified
3 Sep 2015
Reported
9 Sep 2015
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Sterility

Timeline

10 Jul 2015Recall initiated by company
3 Sep 2015Classified by FDA+55 days
9 Sep 2015Published 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

EENT PACK I (1) 10/CS CUSTOMED 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?

Code:9002498 Lots: 150116588 exp. 1/31/16 150116586 exp. 1/31/16 150116587 exp. 1/31/16

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

100 other products · FDA event 71721

This product is part of a recall event; the main page for the event is Labor & Delivery 4/CS Used by medical staff to perform recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IILabor & Delivery 4/CS Used by medical staff to perform recalledCustomedSterilityPR
CLASS IIMinor Pack 4/CS Used by medical staff to perform surgical recalledCustomedSterilityPR
CLASS IIGeneral Minor PK 5/CS Used by medical staff to perform recalledCustomedSterilityPR
CLASS IIPremium Arthroscopy PK Customed 5/CS Used by medical staff recalledCustomedSterilityPR
CLASS IIMinor Laceration Tray Customed 50/CS Used by medical staff recalledCustomedSterilityPR
CLASS IIUrology Pack 4/CS Used by medical staff to perform surgical recalledCustomedSterilityPR
CLASS IISurg Gown Polyreinf Lge Custom 28/CS Used by medical staff recalledCustomedSterilityPR
CLASS IIWound Management Customed 20/CS Used by medical staff recalledCustomedSterilityPR
CLASS IIExtremity Arm Pack 4/cs Hosp recalled by CustomedCustomedSterilityPR
CLASS IIWound Closure Tray I Customed 50/CS Used by medical staff recalledCustomedSterilityPR
CLASS IIGauze Sponge 2"X2" 8PLY Cotton/CS Used by medical staff recalledCustomedSterilityPR
CLASS IILaparoscopy Pack 6/CS Used by medical staff to perform recalledCustomedSterilityPR
CLASS IILabor & Delivery 4/CS Used by medical staff to perform recalledCustomedSterilityPR
CLASS IIGown, surgical 30/CS Used by medical staff to perform recalledCustomedSterilityPR
CLASS IICesarean Pack 3/CS Used by medical staff to perform recalled by CustomedCustomedSterilityPR
CLASS IIPeri Gyn Pack 5/CS Used by medical staff to perform recalled by CustomedCustomedSterilityPR
CLASS IIPery Gyn Pack Customed 10/CS Used by medical staff recalledCustomedSterilityPR
CLASS IIOrtho-implant Surgical Pack recalled by CustomedCustomedSterilityPR
CLASS IILaparotomy Pack 4/CS Used by medical staff to perform recalledCustomedSterilityPR
CLASS IIWound Closure Tray II Customed 50/CS Used by medical staff recalledCustomedSterilityPR
CLASS IIHair Restoration Pack-thr 12/CS Used by medical staff recalledCustomedSterilityPR
CLASS IILaparoscopy PK 3/CS Used by medical staff to perform recalledCustomedSterilityPR
CLASS IILaparoscopy-colorectal Surgical Pack 2/CS Used by medical recalledCustomedSterilityPR
CLASS IIPery-gyn Surgical Pack 6/CS Used by medical staff recalled by CustomedCustomedSterilityPR
CLASS IIPeri Gyn Pack 10/CS Used by medical staff to perform recalledCustomedSterilityPR
CLASS IIGown Cool Impev recalled by CustomedCustomedSterilityPR
CLASS IIO.B. Pack Hospital 3/CS Used by medical staff to perform recalledCustomedSterilityPR
CLASS IIAngiodrape Pack Damas 6/CS Used by medical staff to perform recalledCustomedSterilityPR
CLASS IIUrology Pack 5/CS Used by medical staff to perform surgical recalledCustomedSterilityPR
CLASS IILithotomy Pack 10/CS Used by medical staff to perform recalledCustomedSterilityPR
CLASS IIUtility Drape End Product/CS Used by medical staff recalled by CustomedCustomedSterilityPR
CLASS IILap-cholecystectomy Surgical Pack Used by medical staff recalledCustomedSterilityPR
CLASS IIPremium Cesarean Pack Customed 5/CS Used by medical staff recalledCustomedSterilityPR
CLASS IISuture Removal Kit Customed 100/CS Used by medical staff recalledCustomedSterilityPR
CLASS IISuction Catheter Kit Customed 50/CS Used by medical staff recalledCustomedSterilityPR
CLASS IITracheotomy Care Kit Customed 50/CS Used by medical staff recalledCustomedSterilityPR
CLASS IIGown Surg. Poly Reinf. XL Xlong 40/CS Customed Used recalledCustomedSterilityPR
CLASS IIOpen Heart Tray Customed 1/CS Used by medical staff recalledCustomedSterilityPR
CLASS II(2) 10/CS Customed Used by medical staff to perform recalledCustomedSterilityPR
CLASS IIUmbilical Vessel Catheter Kit Customed 8/CS Used by medical recalledCustomedSterilityPR
CLASS IILaparosc. OB GYN PK 5/CS Used by medical staff to perform recalledCustomedSterilityPR
CLASS IILumbar Pack 4/CS Used by medical staff to perform surgical recalledCustomedSterilityPR
CLASS IIFace Pack Mrt 8/CS Customed Used by medical staff recalledCustomedSterilityPR
CLASS IICentral Line Full Body Drape Customed 28/CS Used by medical recalledCustomedSterilityPR
CLASS IIEAR PACK 3/CS Used by medical staff to perform surgical recalledCustomedSterilityPR
CLASS IIArthroscopy Surgical Pack 4/C Used by medical staff recalled by CustomedCustomedSterilityPR
CLASS IIBreast Pack-tpsc 3/CS Used by medical staff to perform recalledCustomedSterilityPR
CLASS IIArthroscopy Pack 3/Cs Used by medical staff to perform recalledCustomedSterilityPR
CLASS IIC-section PK 2/CS Used by medical staff to perform surgical recalledCustomedSterilityPR
CLASS IIOpen Heart Tray 1/CS Used by medical staff to perform recalledCustomedSterilityPR
CLASS IIFace Pack Fjg 8/CS Used by medical staff to perform recalled by CustomedCustomedSterilityPR
CLASS IIShoulder Pack 3/CS Used by medical staff to perform recalled by CustomedCustomedSterilityPR
CLASS IIEAR PACK 3/CS Used by medical staff to perform surgical recalledCustomedSterilityPR
CLASS IIPediatric Lap Pack 8/CS Used by medical staff to perform recalledCustomedSterilityPR
CLASS IILaparotomy Pack CS/6 Used by medical staff to perform recalledCustomedSterilityPR
CLASS IIOB PACK CS/4 Used by medical staff to perform surgical recalledCustomedSterilityPR
CLASS IIE.N.T. PK 7/CS Used by medical staff to perform surgical recalledCustomedSterilityPR
CLASS IIFemoral Pack 4/CS Used by medical staff to perform surgical recalledCustomedSterilityPR
CLASS IIImplante DE Orthopedia 3/CS Used by medical staff recalled by CustomedCustomedSterilityPR
CLASS IIBreast Pack-bod 6/CS Used by medical staff to perform recalledCustomedSterilityPR
CLASS IILaparotomy Pack 3/CS Used by medical staff to perform recalledCustomedSterilityPR
CLASS IIOrthopedic Pack Basic 5/CS Used by medical staff to perform recalledCustomedSterilityPR
CLASS IILaparoscopy Chole 4/CS Used by medical staff to perform recalledCustomedSterilityPR
CLASS IILaparoscopy Pack 2/CS Used by medical staff to perform recalledCustomedSterilityPR
CLASS IIFoley Catheter Kit II 20/CS Used by medical staff recalled by CustomedCustomedSterilityPR
CLASS IIPremium Laparotomy PK Customed 6/CS Used by medical staff recalledCustomedSterilityPR
CLASS IIObstetrical Surgical Pack 4/CS Used by medical staff recalledCustomedSterilityPR
CLASS IIKnee Arthroscopy PK 4/CS Used by medical staff to perform recalledCustomedSterilityPR
CLASS IIGown Surg. Poly Reinf. XL Xlong 40/CS Customed Used recalledCustomedSterilityPR
CLASS IIHip Ortho. Pack 3/CS Used by medical staff to perform recalledCustomedSterilityPR
CLASS IIDressing Change Customed 50/CS Used by medical staff recalledCustomedSterilityPR
CLASS IICesarean Pack 5/CS Used by medical staff to perform recalled by CustomedCustomedSterilityPR
CLASS IIMayo Stand Cover W/Csr Wrap 30/CS Used by medical staff recalledCustomedSterilityPR
CLASS IIC-section Surgical Pack 2/CS Used by medical staff recalled by CustomedCustomedSterilityPR
CLASS IILaparotomy Basic Pack 10/CS Used by medical staff recalled by CustomedCustomedSterilityPR
CLASS IIExtremity Pack 4/CS Used by medical staff to perform recalledCustomedSterilityPR
CLASS IIO.B. PK 4/CS Used by medical staff to perform surgical recalledCustomedSterilityPR
CLASS IIAngiography Pack Customed 4/CS Used by medical staff recalledCustomedSterilityPR
CLASS IILaparoscopy PK 4/CS Used by medical staff to perform recalledCustomedSterilityPR
CLASS IIFanfold Drape 44"X58 60/CS Used by medical staff to perform recalledCustomedSterilityPR
CLASS IIShoulder Pack (I) 6/CS Customed Used by medical staff recalledCustomedSterilityPR
CLASS IIBasic Pack W/Out Gown 11/CS Used by medical staff recalled by CustomedCustomedSterilityPR
CLASS IICesarean Pack 4/CS Used by medical staff to perform recalled by CustomedCustomedSterilityPR
CLASS IIMinor Laparotomy PK 5/CS Used by medical staff to perform recalledCustomedSterilityPR
CLASS IIUrethral Catheter Tray Customed 50/CS Used by medical staff recalledCustomedSterilityPR
CLASS IIEndovenous Custom Pack 5/CS Customed Used by medical staff recalledCustomedSterilityPR
CLASS IIUniversal Pack 3/CS Used by medical staff to perform recalledCustomedSterilityPR
CLASS IICysto Tur Pack Customed 10/cs Rev recalledCustomedSterilityPR
CLASS IIGown Impervious Extra Long 24/CS Used by medical staff recalledCustomedSterilityPR
CLASS IINeuro Spine Pack 3/CS Used by medical staff to perform recalledCustomedSterilityPR
CLASS IIFoley Cath Kit recalled by CustomedCustomedSterilityPR
CLASS IILaparoscopy-gyn Surgical Pack Used by medical staff recalled by CustomedCustomedSterilityPR
CLASS IIGauze Sponge 4"X4" 16 Ply Soft 1280/CS Used by medical recalledCustomedSterilityPR
CLASS IIArthroscopy Pack 3/CS Used by medical staff to perform recalledCustomedSterilityPR
CLASS IIIrrigation Tray W/Bulb Syringe Customed 50/CS Used recalledCustomedSterilityPR
CLASS IITummy Tuck & Breast Pack-rfmhi 6/CS Used by medical staff recalledCustomedSterilityPR
CLASS IIIncision And Drainage Tray 50/CS Used by medical staff recalledCustomedSterilityPR
CLASS IIShoulder Arthroscopy Pack 3/CS Used by medical staff recalledCustomedSterilityPR
CLASS IIGauze 2" X 2" Production Only/CS Customed Used by medical recalledCustomedSterilityPR
CLASS IIShoulder Arthroscopy Pack 2/CS Used by medical staff 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

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