Cook Zenith Alpha Abdominal Endovascular Graft Recall for Damaged Safety Lock Knob
Cook Inc. is recalling Zenith Alpha Abdominal Endovascular Grafts that may contain a damaged gray safety lock knob, which could prevent full deployment of the graft.
What this means for you
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 involves a medical device defect that could lead to a prolonged procedure and open surgical intervention, representing a risk of harm where injury has not yet been reported, consistent with a High severity rating.
Plain-English summary
Cook Inc. is recalling 1,027 units of the Zenith Alpha Abdominal Endovascular Graft. The recall is due to a potential defect where the product may contain a damaged gray safety lock knob. This defect could result in difficulty or an inability to fully deploy the graft using the standard or troubleshooting methods provided in the Instructions for Use (IFU).
The product was distributed to foreign countries including Australia, Austria, Belgium, Brazil, Canada, and others, but there was no US distribution. The source text does not specify the exact number of affected units or the specific dates of distribution.
Potential adverse events if an affected product is used include a prolonged procedure and the need for open surgical intervention. Consumers and healthcare providers should check their inventory for the specific reference part numbers and lot codes listed in the official recall notice and contact Cook Inc. for further instructions.
The recalled product
- Product
- Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108, ZIMB-22-118, ZIMB-22-128, ZIMB-22-70, ZIMB-22-84, ZIMB-22-98, ZIMB-24-108, ZIMB-24-118, ZIMB-24-128, ZIMB-24-70, ZIMB-24-84, ZIMB-24-98, ZIMB-26-108, ZIMB-26-118, ZIMB-26-128, ZIMB-26-70, ZIMB-26-84,
- Manufacturer
- Cook Inc.
- Affected units
- 1,027
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)
- 9221784
- 9228731
- 9232249
- 9246529
- 9272685
- 9272835
- 9276029
- 9276400
- 9303245
- 9373623
- 9406776
- 9466908
- 9506559
- 9525188
- 9557569
- 9566160
- 9566211
- 9575380
- 9620378
- 9620379
Distribution
Distribution scope not specified by the agency.
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