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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (surgical kit) where injury has not yet been reported, fitting the criteria for a High severity score.
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
- 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
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.
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