Cook guidewires recalled for compromised sterility due to packaging breach
Cook Incorporated is recalling Amplatz extra Stiff Wire Guides because packaging seals may be completely breached, potentially compromising device sterility.
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 sterile medical devices with potential loss of sterility from packaging breach—a risk-of-harm product where injury has not yet been reported. Per the severity rubric, such products are scored as High (3).
Plain-English summary
Cook Incorporated is recalling 204 Amplatz extra Stiff Wire Guides with reference part numbers THSF-35-145-AES-SGH and THSF-38-80-AES-SGH. The devices may have a complete breach of the chevron seal in the packaging, which could compromise the sterility of the affected devices.
Affected lots are Lot 14767453 (expiration date 02-06-2027) and Lot 14802152 (expiration date 20-06-2027). The devices have been distributed nationwide in the United States and worldwide outside the United States.
Healthcare providers with affected inventory and patients who may have received these devices should contact Cook Incorporated immediately. Affected devices should not be used. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number: THSF-35-145-AES-SGH (GPN G06801) THSF-38-80-AES-SGH (GPN G06874)
- Manufacturer
- Cook Incorporated
- Affected units
- 204
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)
- Expiration Date 20-06-2027
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 24 recalled by Cook Incorporated 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.
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