Boston Scientific Corporation: CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Boston Scientific Corporation
- Product
- CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);
- Reason / hazard
- The potential for devices to experience inflation and/or deflation performance issues or difficulties.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide distribution - US Nationwide and the country of Canada.
- Recall initiated
- 2025-09-11
- Code info
- 1. UPN: 72404486 (15CM IP); UDI-DI: 00191506021658; Lot numbers: 1100676851, 1100676852; 2. UPN: 72404488 (21CM IP); UDI-DI: 00191506021672; Lot numbers: 1100717673;
- Product quantity
- 1 unit
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Marlborough
- State
- MA
- Country
- United States
- Event id
- 97603
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