Medline Angio Drape Pack Recall Due to Sterility Misidentification
Medline is recalling 105 Angio Drape Packs because a non-sterile waste bag was assumed to be sterile by customers.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: This is a Class II recall involving a labeling error where a non-sterile component was assumed to be sterile, fitting the criteria for minor labeling errors or low-risk contamination without reported injuries.
Plain-English summary
Medline Industries Inc is recalling 105 units of the Medline Angio Drape Pack Radiology-LF. This sterile custom single patient prescription procedure pack is used by the Interventional Radiology Department and includes a waste bag. The affected packs were distributed in New York.
The recall is due to a labeling and identification issue. The non-sterile Waste Bag component was attached to the outside of the pack in its own packaging. Although the product was not labeled or identified as sterile, it was assumed to be sterile by the customer.
Customers who have purchased or received these packs should stop using them and contact Medline Industries Inc for further instructions. The specific lot numbers involved are 12HD2126, 12IB5014, and 12JB8311.
The recalled product
- Product
- Medline Angio Drape Pack Radiology-LF; a sterile custom single patient prescription procedure pack, including a waste bag, for use by the Interventional Radiology Department; Packaged for Medline Industries, Inc.; Reorder #DYNJ35993D This custom pack includes components…
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — Surgical Packs
- Hazard
- Affected units
- 105
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 (5)
- Reorder #DYNJ35993D
- lot numbers 12HD2126
- exp. 5/31/2015
- 12IB5014
- exp. 7/31/2015 and 12JB8311
Distribution
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