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.
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 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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