[pending] CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM PS IZ), (2) 7240446
Pending LLM rewrite. Source: FDA_DEVICE Z-0143-2026.
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: Pending LLM scoring against the rubric.
Plain-English summary
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
The recalled product
- Product
- CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM PS IZ), (2) 72404462 (14CM PS IZ), (3) 72404463 (16CM PS IZ), (4) 72404464 (18CM PS IZ), (5) 72404465 (10CM IP IZ), (6) 72404466 (12CM IP IZ), (7) 72404467 (14CM IP IZ), (8) 72404468 (16CM IP IZ), (9
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Devices
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)
- 1. UPN: 72404461 (12CM PS IZ)
- UDI-DI: 00191506021504
- Lot numbers: 1100398868
- 1100398869
- 1100398870
- 1100398871
- 1100398872
- 1100398873
- 1100398874
- 1100398875
- 1100398876
- 1100398877
- 1100522368
- 1100543829
- 1100574579
- 1100590200
- 1100590204
- 1100590209
- 1100599084
- 1100599107
Distribution
Distributed nationwide across the United States.
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