[pending] Medical convenience kits Item Number/Description RCGY52D GYN LAPAROSCOPY SPH 0246965 UIGN82M G
Pending LLM rewrite. Source: FDA_DEVICE Z-0179-2026.
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
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
The recalled product
- Product
- Medical convenience kits Item Number/Description RCGY52D GYN LAPAROSCOPY SPH 0246965 UIGN82M GYN (PS 907645) UIHY16AE ASC HYSTEROSCOPY PACK (PS 020634)
- Manufacturer
- American Contract Systems Inc.
- 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 (5)
- FHGY09S UDI-DI 191072234360 lot 8532011 bag serial number 68874879
- LMGY39U UDI-DI 191072209337 Lot 8490211 bag serial numbers 47860009 47861175
- OWGY11Q UDI-DI 191072236555 lot 8389711 bag serial number 17622382
- RCGY52D UDI-DI 191072232670 lot 8142411 bag serial number 17487909
- then entire lot is affected
Distribution
Distributed nationwide across the United States.
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