Medline Recalls Surgical Kits With Flaking Guidewire Coating
Medline Industries is recalling 304 surgical kits containing guidewires with a potential for coating to flake off.
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 for coating to flake off, which poses a risk of harm to patients during surgical procedures, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Medline Industries, Inc. is recalling 304 units of CATH TRAY surgical kits, reference number DYNJ41101, lot 13FB5744. These kits are used to supply tools required to perform angiography medical procedures.
The recall is due to a potential for the coating on the Guidewire .035x150 3MMJ TCFC (item number 88241) to flake off the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc.
The affected products were distributed nationwide to the states of Alabama, California, Florida, Illinois, Louisiana, Ohio, and Virginia. Consumers and healthcare facilities should stop using the affected kits and contact Medline Industries for further instructions.
The recalled product
- Product
- CATH TRAY; REF: DYNJ41101; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.
- Manufacturer
- Medline Industries, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 304
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: DYNJ41101
- Lot: 13FB5744
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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