[pending] Medical convenience kits Item number/ Product description AKGN82E GENERAL AMCB08Y CHEST BREAST
Pending LLM rewrite. Source: FDA_DEVICE Z-0172-2026.
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/ Product description AKGN82E GENERAL AMCB08Y CHEST BREAST PACK ANBP10AC BASIC PACK - 205939 ANIR77AM INTERVENTIONAL RADIOLOGY PACK - 205953 CFLA39G LAPAROTOMY PACK CIBL33I BASIC LAP PACK EVMN24E MINOR ESC EVST48E STARTER FDTA11AA
- 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 (20)
- AKGN82E UDI-DI 191072229281 Lot 7352211 Bag serial number 47384448
- AMCB08Y UDI-DI 191072185082 Lot 8069911 Bag serial number 68117042
- ANBP10AC UDI-DI 191072214300 Lot 8125811 Bag serial numbers 17487164 17488117
- CFLA39G UDI-DI 191072203496 Lot 8484911 Bag serial numbers 68642706
- CIBL33I UDI-DI 191072186409 Lot 8044011 Bag serial number N/A
- EVMN24E UDI-DI 191072215093 Lot 8184711 Bag serial number 68198257
- EVST48E UDI-DI 191072224064 Lot 7366711 Bag serial number 68194868
- FDTA11AA UDI-DI 191072159236 Lot 8522811 Bag serial number 47864258
- FHHY25P UDI-DI 191072157256 Lot 8031711 Bag serial number 68152897
- HGML99G UDI-DI 191072212580 Lot 8316911 Bag serial number 68244067
- HGXR41H UDI-DI 191072212672 Lot 8285311 Bag serial number N/A
- HISU54M UDI-DI 191072212399 Lot 7969611 Bag serial number 17427513
- IHAA19AP UDI-DI 191072224187 Lot 8035011 Bag serial number 68048038
- IHMP89K UDI-DI 191072159960 Lot 8024811 Bag serial number 68154486
- IHPD14AM UDI-DI 191072227232 Lot 8180911 Bag serial number 68200149
- LKVG10O UDI-DI 191072158666 Lot 7957411 Bag serial number N/A
- LMAG20G UDI-DI 191072158680 Lot 7964411 Bag serial number N/A
- LMLE46AA UDI-DI 191072237880 Lot 8500811 Bag serial number 68642780
- MIEN58A UDI-DI 191072231444 Lot 8118411 Bag serial number N/A
- NUMB04H UDI-DI 191072202895 Lot 7993111 Bag serial number N/A
Distribution
Distributed nationwide across the United States.
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