[pending] Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 6
Pending LLM rewrite. Source: FDA_DEVICE Z-1492-2026.
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
Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life. Device expiry should have been calculated from gel impregnation (date of manufacture) but it was incorrectly calculated from device packaging.
The recalled product
- Product
- Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 631516PE, 636016PE, 631220PE, 631608PE, 631206PE, 631407P50E, 631508PE, 636008PE, 636006PE, 632518PE, 634008PE, 634006PE, 631218PE, 632211PE, 634007PE, 633006PE,
- Manufacturer
- Vascutek, Ltd.
- 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)
- All Gelsoft Plus devices (any item number ending 'E-B' e.g. 631206PE-B)
- REF
- Item Number
- UDI-DI(GTIN): 635024PE
- 635024PE-B
- 5037881166636
- 631514PE
- 631514PE-B
- 5037881166858
- 631222PE
- 631222PE-B
- 5037881166896
- 633008PE
- 633008PE-B
- 5037881166698
- 633010PE
- 633010PE-B
- 5037881166711
- 633007PE
- 633007PE-B
Distribution
Distributed nationwide across the United States.
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