Medline Recalls Angiography Packs Due to Guidewire Coating Flaking Risk
Medline Industries is recalling 1,194 angiography packs because a guidewire component may have flaking coating. The recall covers distribution in seven 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 for coating flaking, which poses a risk of harm during surgical procedures. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
Medline Industries, Inc. is recalling 1,194 units of the Angiography Pack (Reference: DYNJ26855D). The recall is due to a potential defect in the Guidewire .035x150 3MMJ TCFC (item number 88241), where the coating on the wire has a potential to flake off. This guidewire is used in surgical convenience kits assembled and marketed by Medline.
The affected products were packaged in Mexico by Medline Industries, Inc., located in Mundelein, IL. The specific lots involved are 13EB2046 and 13EB8965. These 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 angiography packs and contact Medline Industries at 1-800-Medline or visit www.medline.com for further instructions on how to return or dispose of the product.
The recalled product
- Product
- ANGIOGRAPHY PACK; REF: DYNJ26855D; 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
- 1,194
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: DYNJ26855D
- Lots: 13EB2046
- 13EB8965
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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