Teleflex Auto Endo5 Hem-o-lok Clip Applier Recall for Missing Boss
Teleflex Medical is recalling Auto Endo5 Hem-o-lok clip appliers because the clip may be missing a boss, which is needed to hold the clip in the applier jaws.
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 mechanical defect in a medical device used for vessel ligation, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Teleflex Medical is recalling 543 units of the Auto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips (REF 543965). These devices are indicated for use as delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips in procedures involving the ligation of vessels or tissue structures.
The recall is due to a defect where the clip in the applier may be missing a boss. A boss is the part of the clip used to hold the clip within the applier jaws prior to application. The affected lots are identified by the following codes: 73J1500065, 73J1500066, 73J1500280, 73J1500440, 73J1500565, 73J1500566, and 73K1500193.
The affected products were distributed worldwide in the states of California, Michigan, North Carolina, Pennsylvania, Texas, and Virginia, as well as in Canada, Korea, and Belgium. The source text does not specify instructions for consumers or healthcare providers regarding the next steps for these recalled devices.
The recalled product
- Product
- Auto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips, Rx Only, Sterile, REF 543965 Product Usage: The Weck Auto Endo5 hem-o-lok ML automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-lok ML non-absorbable…
- Manufacturer
- Teleflex Medical
- Hazard
- Affected units
- 543
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 (7)
- 73J1500065
- 73J1500066
- 73J1500280
- 73J1500440
- 73J1500565
- 73J1500566
- 73K1500193
Distribution
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