[pending] CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21C
Pending LLM rewrite. Source: FDA_DEVICE Z-0140-2026.
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
- CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);
- 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 (7)
- 1. UPN: 72404486 (15CM IP)
- UDI-DI: 00191506021658
- Lot numbers: 1100676851
- 1100676852
- 2. UPN: 72404488 (21CM IP)
- UDI-DI: 00191506021672
- Lot numbers: 1100717673
Distribution
Distributed nationwide across the United States.
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