Teleflex RUSCH Pocket Pac Urinary Catheter Kit Recalled for Sterility Concerns
Teleflex Medical recalled approximately 7,200 RUSCH Pocket Pac i.c. urinary catheter kits due to potential sterility issues. Patients should contact their healthcare provider and discontinue use.
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: This is an FDA Class II medical device recall with a sterility concern but no reported illnesses or injuries. Per the rubric, recalls of risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Teleflex LLC has recalled approximately 7,200 units of the RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm). The product may not be sterile. The affected catheters were distributed to customers in Tennessee, California, North Carolina, Texas, Florida, Ohio, Missouri, Illinois, and Oregon.
Patients who have received or may receive one of the affected catheters should contact their healthcare provider immediately. Patients should not use the recalled product and should seek guidance on appropriate alternatives.
The recalled product
- Product
- Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter.
- Manufacturer
- TELEFLEX LLC
- Hazard
- Affected units
- 7,200
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)
- UDI (01)24026704323245(17)250405(10)74E2200810
Distribution
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