Maquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
Maquet Cardiopulmonary GmbH is recalling Percutaneous Insertion Kits because packaging may not consistently maintain sterile barrier integrity.
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: The recall involves a medical device where the sterile barrier integrity may be compromised, posing a risk of harm (infection) even though no injuries or illnesses have been reported yet. This aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Maquet Cardiopulmonary GmbH is recalling Percutaneous Insertion Kits (PIK), Guidewire 100 cm, Model Numbers 701053068 (USA) and 701047384 (OUS). The recall involves 68,371 units, including 1,765 units in the US and 66,606 units outside the US. The product was distributed worldwide, including in the United States, Australia, Austria, and other countries.
The recall was initiated because the packaging may not consistently maintain sterile barrier integrity. This defect could potentially compromise the sterility of the medical device. The source text does not report any specific illnesses, injuries, or deaths associated with this recall.
Healthcare facilities and consumers should stop using the affected Percutaneous Insertion Kits and contact Maquet Cardiopulmonary GmbH for instructions on return or replacement. The recall number is Z-3144-2026.
The recalled product
- Product
- Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS);
- Manufacturer
- Maquet Cardiopulmonary Gmbh
- Category
- Medical Device — Cardiovascular
- Hazard
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)
- Model Number (USA): 701053068
- UDI-DI: 4037691519883
- Lot Numbers: 3000324477
- 3000333824
- 3000336037
- 3000341450
- 3000343893
- 3000377475
- 3000387891
- 3000403656
- 3000414516
- 3000430803
- 3000441821
- 3000453326
- 3000471523
- 3000476321
- 3000485151
- 3000496204
- 3000510428
- 3000518006
Distribution
Distributed nationwide across the United States.
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