Medline Recalls Surgical Kits with Potential Coating Defect on Guidewires
Medline Industries is recalling 10 surgical kits containing guidewires with a potential coating defect. The kits were distributed to specific US states.
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 medical device with a potential defect (coating flaking) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Medline Industries, Inc. is recalling 10 units of sterile surgical kits, identified by reference number SAMP0144. These kits are used to supply tools required to perform medical procedures and were distributed nationwide to the states of Alabama, California, Florida, Illinois, Louisiana, Ohio, and Virginia.
The recall is due to a potential defect in the Guidewire .035x150 3MMJ TCFC (item number 88241) included in the kits. The source text states that the coating on the guidewire has a potential to flake off. The affected lots are 13CD2145 and 13CD2146.
The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice itself. No illnesses or injuries are reported in the provided text.
The recalled product
- Product
- STERILE SAMPLE BUILD; REF: SAMP0144; 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
- Affected units
- 10
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 (3)
- Pack Number: SAMP0144
- Lots: 13CD2145
- 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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