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, posing a risk of infection.
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, creating a risk of infection (harm) without reported injuries, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Maquet Cardiopulmonary Gmbh is recalling the Percutaneous Insertion Kit (PIK), dilator set L, Model Number 701054427. The recall affects 16,697 units, including 492 units in the United States and 16,205 units in other countries. The product was distributed worldwide, including in the US, Australia, Canada, and various European and Asian nations.
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, which is a critical safety requirement for percutaneous insertion kits used in medical procedures.
Healthcare providers and facilities that have received these specific model and lot numbers should stop using the affected kits. Users should contact Maquet Cardiopulmonary Gmbh for instructions on how to return or dispose of the recalled product. No specific illnesses or injuries have been reported in the source text, but the potential loss of sterility presents a significant risk of infection if the device is used.
The recalled product
- Product
- Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA), 701054427 (OUS);
- Manufacturer
- Maquet Cardiopulmonary Gmbh
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): 701054427
- UDI-DI: 4037691746517
- Lot Numbers: 3000324476
- 3000326923
- 3000331200
- 3000333822
- 3000353373
- 3000359477
- 3000364060
- 3000373784
- 3000379853
- 3000393466
- 3000403658
- 3000413596
- 3000434593
- 3000444270
- 3000449725
- 3000453328
- 3000478750
- 3000524542
Distribution
Distributed nationwide across the United States.
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