Z-2249-2025Class II
GS ENDOSCOPY PACK. Medical convenience kit
Avid Medical, Inc. a Medical Action Ind. Company 305 / initiated 2025-06-11 / Open, Classified / root cause: sterility
AVID Medical, Inc. began a recall of GS ENDOSCOPY PACK. Medical convenience kit on . FDA classified it as Class II and gives the reason as "CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration". As of , the recall status on record is Open, Classified, and MDM tags the root cause as sterility.
Recall record
- Recall number
- Z-2249-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Avid Medical, Inc. a Medical Action Ind. Company 305
- Product
- GS ENDOSCOPY PACK. Medical convenience kit.
- Product code
- LRO General Surgery Tray
- Reason for recall
- CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- Root cause tag
- sterility
- FDA root cause
- Under Investigation by firm
- Action
- Consignees were sent an URGENT: MEDICAL DEVICE FIELD CORRECTION notice, dated 6/11/25, via email. The notification instructs consignees to not use the CLEARIFY Visualization System (component #5303907) and discard. All other components in the kit may be continued to be used. Consignees are to add warning labels to affected procedure trays to ensure the affected component is discarded. The provided Recall Response Form is to be completed and returned to Owens&Minor. Any quality problems or adverse events associated with recalled devices may be reported via email to [email protected]
- Quantity in commerce
- 816 units
- Distribution
- Domestic: CA, IL, MD, OH, PA, TX, WA.
- Product codes and lots
- Model No. NAMC421-10, NAMC421-11, NAMC421-12; UDI: 10809160374597, 10809160417539, 10809160435779; Kit Lot No. 1584375, 1588403, 1605341, 1615427, 1615428, 1627706, 1628153, 1628008, 1628009, 1628647, 1632992.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2240-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2241-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2242-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2243-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2244-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2245-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2246-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2247-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2248-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2249-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2250-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2251-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2252-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2253-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2254-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2255-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2256-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2257-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2258-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2259-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2260-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2261-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2262-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2263-2025 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
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