Medline Recalls Sterile Sample Cath Lab Packs Due to Coating Defect
Medline Industries is recalling 10 units of Sterile Sample Cath Lab Packs because a guidewire component has a potential for its coating to flake off.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which typically indicates a low risk of adverse health consequences. The hazard is a potential coating defect on a guidewire, and no injuries or illnesses are reported in the source text.
Plain-English summary
Medline Industries, Inc. is recalling 10 units of Sterile Sample Cath Lab Packs (Reference: SAMP0213). These surgical kits are used to supply tools required to perform 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 on the wire has a potential to flake off.
The affected products were distributed nationwide to the states of Alabama, California, Florida, Illinois, Louisiana, Ohio, and Virginia. The specific lot number for the recalled items is 13CD1774.
Consumers and healthcare facilities should stop using the affected Sterile Sample Cath Lab 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
- STERILE SAMPLE CATH LAB PACK; REF: SAMP0213; 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
- Hazard
- 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 (2)
- Pack Number: SAMP0213
- Lot: 13CD1774
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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