Teleflex Recalls Hem-o-lok Polymer Clips Due to Sterility Concerns
Teleflex Medical is recalling 126 units of Hem-o-lok Large Polymer Ligating Clips because pinholes in the trays may compromise sterility.
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 3/5 (High).
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 is classified as FDA Class II, and the hazard involves a risk of harm (loss of sterility) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Teleflex Medical is recalling 126 units of Hem-o-lok Large Polymer Ligating Clips, Catalog No. 544240, Lot #01E1200585. These are single-use, sterile, non-absorbable medical devices designed to ligate vessels and tissue structures during surgical procedures. The recall is due to the possibility that the trays may contain pinholes, which could compromise the sterility of the product.
The affected units were distributed nationwide, including the state of Nevada. The source text does not specify the exact number of units distributed to specific facilities or the exact dates of distribution.
Healthcare providers and facilities should stop using the affected lots immediately and contact Teleflex Medical for further instructions on returning the product. Patients who have had these specific clips used in a surgical procedure should contact their healthcare provider for guidance.
The recalled product
- Product
- Hem-o-lok Large Polymer Ligating Clips, REF #544240, Rx only, Sterile, Teleflex Medical, Research Triangle Park, NC 27709. Teleflex Medicals Hem-o-lok polymer ligating clips are single use, sterile, non-absorbable medial devices that have been designed to ligate vessels and…
- Manufacturer
- Teleflex Medical
- Hazard
- Affected units
- 126
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)
- Catalog No. 544240
- Lot #01E1200585
Distribution
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