Reprocessed electrophysiology catheters recalled over incomplete sterile seals
The CS Uni-Directional with Auto ID reprocessed electrophysiology catheter is being recalled because of incomplete seals on the sterile product. 449 units are affected.
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: FDA Class II recall where the sterile barrier may be compromised on an invasive device, a risk of harm with no injuries reported in the source.
Plain-English summary
The CS Uni-Directional with Auto ID reprocessed electrophysiology catheter, product number D135303, UDI 07613327357301, is being recalled. The action covers 449 units across the lot numbers listed in the recall notice.
The stated reason is incomplete seals on sterile product. A seal that is not complete compromises the sterile barrier protecting the device. The FDA classified the action as Class II.
Distribution was nationwide in the United States and to Israel and Canada. The catheters are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the product number, UDI and lot numbers in the recall notice, quarantine it, and follow the instructions issued by the manufacturer.
The recalled product
- Product
- CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Manufacturer
- Stryker Sustainability Solutions
- Affected units
- 449
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 (20)
- UDI 07613327357301
- Lot Numbers: 2934107
- 3695884
- 3813841
- 3963557
- 4293648
- 4660245
- 4816422
- 4937844
- 4984006
- 5024442
- 2964378
- 3695885
- 3813842
- 3963558
- 4294641
- 4665924
- 4816423
- 4937846
- 4984751
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 26 recalled by Stryker Sustainability Solutions under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 26 products in this recall →Related recalls
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