CLASS II Drug recall · Reported 7 Feb 2018 · FDA Enforcement Report

Professional Hospital Supply Suture Removal Kit, Sterile recalled

Medline Industries is recalling Professional Hospital Supply Suture Removal Kit, Sterile, Single Use Only, distributed nationwide in the US. The recall was initiated on 21 Sep 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPack Number: P888899; Lots 17RB8659; 17GB5162 Pack Number: P888899H; Lots 17RB8659
Quantity recalled779 cases

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-0313-2018
FDA event ID
78575
Recalling firm
Medline Industries, Northfield, IL
Classification
Class II
Status
Terminated
Recall initiated
21 Sep 2017
FDA classified
4 Feb 2018
Reported
7 Feb 2018
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Potency & Assay

Timeline

21 Sep 2017Recall initiated by company
4 Feb 2018Classified by FDA+136 days
7 Feb 2018Published in enforcement report+3 days

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

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Professional Hospital Supply Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Professional Hospital Supply, Inc., 41980 Winchester Rd., Temecula, CA 92590

Where it was distributed

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Which lots are affected?

Pack Number: P888899; Lots 17RB8659; 17GB5162 Pack Number: P888899H; Lots 17RB8659

Where was it sold?

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

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

67 other products · FDA event 78575

This product is part of a recall event; the main page for the event is Medline Suture Removal Tray recalled by Medline Industries.

ReportedClassRecallCompanyReasonWhere
CLASS IIMedline Suture Removal Tray recalled by Medline IndustriesMedline IndustriesPotency & AssayNationwide
CLASS IIMedline General Purpose Kit, Sterile, Single use only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Vitrectomy CDS Pack, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline IV Start Kit, Sterile, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Vaginal Delivery CDS Pack, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Dressing Change Tray Kit, Sterile, Single use only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Suture Removal Tray, Sterile, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Abdominal Surgery II Pack-LF, Sterile, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline General Purpose Instrument Set, Sterile, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Central Line Dressing Change Tray Kit, Sterile recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Incision Drainage Tray, Sterile, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Suture Removal Kit, Sterile, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Newborn Kit recalled by Medline IndustriesMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Incision and Drainage Tray Kit, Sterile, Single use only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Concordia Trunk Kit recalled by Medline IndustriesMedline IndustriesPotency & AssayNationwide
CLASS IIAplicare Povidone-Iodine Prep Pad, Antiseptic recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Pediatric IV Kit recalled by Medline IndustriesMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Suture Removal Tray, Sterile, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Suture Removal Tray, Sterile, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Suture Removal Tray, Sterile, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Rad Neck ENT Tray Pack, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Suture Removal Tray, Sterile, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIProfessional Hospital Supply Suture Removal Kit, Sterile recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Debridement Tray, Sterile, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Incision And Drainage Tray Kit, Sterile, Single use only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Concordia Nurse Bag Kit recalled by Medline IndustriesMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Irrigation W/Piston SYR Tray, Sterile, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Tray, Catheter Care, Lidded recalled by Medline IndustriesMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Wound Closure Tray, Sterile, Single use only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Skin Stapler RMVR, Tray Sterile, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline IV Start Kit, Sterile, Single use only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Suture Removal Tray, Sterile, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Hip Replacement, Kit, Sterile, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Suture Removal Tray, Sterile, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Incision and Drainage Tray, Sterile, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline DC Line Kit, Sterile, Single use only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline I&D Tray Kit, Sterile, Single use only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Suture Removal Pack Latex Safe, Sterile, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Trunk Kit, Non-sterile recalled by Medline IndustriesMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Sheath Removal Kit, Sterile, Single use only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Circumcision Tray Kit, Sterile, Single use only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Catheter Insertion Kit, Sterile recalled by Medline IndustriesMedline IndustriesPotency & AssayNationwide
CLASS IIMedline CC Drawer 4 IV Circulation Pack, Contains Rx recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Cntrl Line Removal Kit Scripps recalled by Medline IndustriesMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Staple Remover Tray, Sterile, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Incision and Drainage Tray, Sterile, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Suture Removal Kit, Sterile, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Staple Remover Kit, Sterile, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Incision & Drainage Tray, Sterile, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Pacemaker Implant Pack, Sterile, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Anesthesia Kit, Single Use Only recalled by Medline IndustriesMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Laceration Tray, Sterile, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline General Purpose Tray, Sterile, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedical Equipment Affiliates IV Start Kit, Sterile, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Skin Biopsy Pack-LF, Sterile, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Skin Staple Remover Kit, Sterile, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline NICC Suture Removal Tray, Sterile, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline General Purpose Tray, Sterile, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Suture Removal Tray, Sterile, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Suture Removal Tray, Sterile, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Incision Drainage Kit, Sterile, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Suture Removal Tray, Sterile, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline GHS Suture Removal Tray, Sterile, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Straight Suture Removal Tray, Sterile, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline Suture Removal Tray, Sterile, Single Use Only recalledMedline IndustriesPotency & AssayNationwide
CLASS IILiberator Medical Supply Catheter Insertion Tray, Sterile recalledMedline IndustriesPotency & AssayNationwide
CLASS IIMedline All Purpose Instrument Tray, Sterile recalledMedline IndustriesPotency & AssayNationwide

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