Medline Recalls Angiography Surgical Kits Due to Guidewire Coating Defect
Medline Industries is recalling 120 surgical kits containing guidewires with a potential coating flaking 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 medical device defect (coating flaking) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for theoretical risk.
Plain-English summary
Medline Industries, Inc. is recalling 120 units of CATH PACK surgical kits (Reference DYNJ41103) used for angiography medical procedures. The recall is due to a potential defect in the Guidewire .035x150 3MMJ TCFC (item number 88241) included in the kits, where the coating may flake off the wire.
The affected products were packaged in Mexico and distributed nationwide to the states of Alabama, California, Florida, Illinois, Louisiana, Ohio, and Virginia. The specific lots involved are 13GB5484 and 13GB9975.
Healthcare facilities and consumers should stop using these kits and contact Medline Industries at 1-800-Medline or visit www.medline.com for further instructions.
The recalled product
- Product
- CATH PACK; REF: DYNJ41103; 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
- 120
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: DYNJ41103
- Lots: 13GB5484
- 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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