Teleflex Horizon 24 Titanium Clips Recalled for Missing Date Labels
Teleflex Medical is recalling Horizon 24 Large Titanium Clips because manufacturing and expiration dates are missing from the blister pack 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 for a documentation and packaging issue (missing dates) with no reported injuries or illnesses, fitting the criteria for a Low severity recall.
Plain-English summary
Teleflex Medical is recalling Horizon 24 Large Titanium Clips with Adhesive Backing (Ref 004204). The recall is due to a labeling defect where the manufacturing and expiration dates are not printed on the blister pack label.
The affected product consists of 8,220 units of sterile, prescription-only metal ligating clips intended for use in procedures involving vessels or anatomic structures. The specific lot number is 01J1200435.
The product was distributed in the United States to the states of AL, AZ, CA, CT, FL, IL, KY, MD, MI, MN, NM, NY, NC, OR, PA, SC, TX, VA, WA, and WI, as well as internationally to Canada. Healthcare facilities and consumers should check for this specific lot number and stop using the product if the dates are missing.
The recalled product
- Product
- Horizon 24 Large Titanium Clips with Adhesive Backing, Ref 004204, Rx Only, Sterile. The metal ligating clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice. An implantable clip…
- Manufacturer
- Teleflex Medical
- Hazard
- Affected units
- 8,220
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 (1)
- Lot/Serial Number 01J1200435
Distribution
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