Maquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
Maquet is recalling Percutaneous Insertion Kits because the packaging may not consistently maintain sterile barrier integrity.
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 with a potential loss of sterile barrier integrity, which poses a risk of harm (infection) even though no injuries have been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Maquet Cardiopulmonary Gmbh is recalling Percutaneous Insertion Kits (PIK), Guidewire 150 cm, Model Numbers 701053069 (USA) and 701047385 (OUS). The recall is due to a defect where the packaging may not consistently maintain sterile barrier integrity.
The affected units were distributed worldwide, including the United States and numerous international markets. The source text does not specify the exact number of units affected, the specific dates of distribution, or any reported illnesses or injuries associated with the defect.
Healthcare providers and consumers should stop using the affected Percutaneous Insertion Kits and contact Maquet Cardiopulmonary Gmbh for instructions on return or replacement.
The recalled product
- Product
- Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS);
- Manufacturer
- Maquet Cardiopulmonary Gmbh
- Category
- Medical Device — Cardiopulmonary
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): 701053069
- UDI-DI: 4037691730677
- Lot Numbers: 3000324478
- 3000326922
- 3000336965
- 3000339840
- 3000347863
- 3000370471
- 3000374104
- 3000379854
- 3000382443
- 3000395582
- 3000403657
- 3000414517
- 3000430804
- 3000434603
- 3000444269
- 3000445982
- 3000453327
- 3000466026
Distribution
Distributed nationwide across the United States.
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