Reprocessed Electrophysiology Catheter Recall Due to Incomplete Seals
Stryker Sustainability Solutions is recalling 816 units of CS Uni-Directional w Auto ID reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging.
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 recall of a sterile medical device with a potential breach of product sterility, which creates a risk of serious adverse health consequences, and no reported illnesses have been stated in the source text. The hazard (sterility compromise via incomplete seals) is a risk-of-harm concern without reported injury, meeting the High (3) threshold.
Plain-English summary
Stryker Sustainability Solutions is recalling CS Uni-Directional w Auto ID reprocessed electrophysiology catheters (Product Number D135304) due to incomplete seals on the sterile product. A total of 816 units have been distributed nationwide in the United States and to Israel and Canada.
The incomplete seals on the sterile packaging could compromise product sterility and safety. Affected units are identified by UDI 07613327357318 and include numerous lot numbers spanning from 3351120 through 5086667.
Patients and healthcare providers who have received this product should contact Stryker Sustainability Solutions or their healthcare facility for further guidance on the recall and any necessary actions. Healthcare facilities should quarantine affected units and not use them for patient care.
The recalled product
- Product
- CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Manufacturer
- Stryker Sustainability Solutions
- Affected units
- 816
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 07613327357318
- Lot Numbers: 3351120
- 4756053
- 4820613
- 4880639
- 4937971
- 4953195
- 4974710
- 5002528
- 5033775
- 5067727
- 3351123
- 4761288
- 4821747
- 4880648
- 4937973
- 4953196
- 4975470
- 5002529
- 5033776
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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