Agency classClass IOur severity:Severe FDA (Devices)·Z-1054-2014·Announced 2014-03-05

Medline Recalls Surgical Kits with Flaking Guidewire Coating

Medline Industries is recalling five surgical kits containing a guidewire with a potential coating flake-off defect.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc."

Plain-English summary

Medline Industries, Inc. is recalling five units of sterile surgical kits (Reference SAMP0147) that contain a specific guidewire. The guidewire, identified as item number 88241 (Guidewire .035x150 3MMJ TCFC), has a potential for the coating to flake off the wire.

The affected kits were distributed nationwide to the states of Alabama, California, Florida, Illinois, Louisiana, Ohio, and Virginia. The specific lot number is 13CD2146 and the pack number is SAMP0147.

Consumers should check their inventory for these specific kits and stop using them if found. The recall is due to the potential for the guidewire coating to flake off, which could affect the integrity of the medical device during surgical procedures.

The recalled product

Product: STERILE SAMPLE BUILD; REF: SAMP0147; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.
Manufacturer: Medline Industries, Inc.
Category: Medical Device — Surgical Kits
Hazard: coating-flaking
Affected units: 5

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Pack Number: SAMP0147
Lot: 13CD2146

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Part of a larger recall action

This product is one of 11 recalled by Medline Industries, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 11 products in this recall →

Same manufacturer · Medline Industries, Inc.

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Same hazard · coating flaking