Medline Recalls Surgical Kits with Flaking Guidewire Coating
Medline Industries is recalling 112 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 risk-of-harm product (medical device) where the hazard is a potential defect (coating flaking) and no injuries or illnesses have been reported in the source text.
Plain-English summary
Medline Industries, Inc. is recalling 112 units of CATH PACK surgical kits (Reference DYNJ40904, Lot 13GB9975). These kits are used to supply tools required to perform medical procedures. The recall is due to a potential for the coating on the included Guidewire .035x150 3MMJ TCFC (item number 88241) to flake off of the wire.
The affected products were distributed nationwide to the states of Alabama, California, Florida, Illinois, Louisiana, Ohio, and Virginia. The kits were packaged in Mexico for Medline Industries, Inc., located in Mundelein, IL.
Healthcare facilities and consumers should stop using the affected surgical kits and contact Medline Industries at 1-800-Medline or visit www.medline.com for further instructions.
The recalled product
- Product
- CATH PACK; REF: DYNJ40904; Packaged in Mexico 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
- 112
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: DYNJ40904
- Lot: 13GB9975
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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