Teleflex Recalls Weck Hemoclip Ligating Clips Due to Labeling Error
Teleflex Medical is recalling 3,180 units of Weck Hemoclip Ligating Clips because manufacturing and expiration dates were transposed on the packaging labels.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because it involves a documentation and labeling error (transposed dates) with no reported injuries or adverse health consequences, fitting the rubric criteria for packaging-only problems.
Plain-English summary
Teleflex Medical is voluntarily recalling 3,180 units of WECK Hemoclip Traditional Medium Tantalum Ligating Clips. The recall was initiated because the manufacturing dates and expiration dates were transposed on the Tyvek labels.
The affected product is identified by Product Code 523300 and Lot number 01B140034. These clips are intended for use in surgical procedures involving vessels or anatomic structures where ligating clips are determined to be the best choice.
The products were distributed nationwide in the United States, including in Alabama, California, Florida, Delaware, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Minnesota, North Carolina, Nebraska, New Jersey, New York, Nevada, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Vermont, and Washington. Healthcare providers and facilities should check their inventory for this specific lot number and stop using the affected clips.
The recalled product
- Product
- WECK Hemoclip¿ Traditional Medium Tantalum Ligating Clips. Weck Ligating Clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice.
- Manufacturer
- Teleflex Medical
- Hazard
- Affected units
- 3,180
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)
- Product Code: 523300
- Lot number: 01B1400034
Distribution
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