Halyard MINOR PACK. Model/Catalog Number: VASF105-08.
AVID Medical, Inc. · Potential for open seals on header bags, compromising sterility.
Open FDA's page for this record- Cfres ID
- 223012
- Product res number
- Z-0331-2027
- Event date initiated
- 2026-09-08
- Event date posted
- 2026-11-03
- Recall status
- Open, Classified
- Res event number
- 99967
- Product code
- LRO
- Product description
- Halyard MINOR PACK. Model/Catalog Number: VASF105-08.
- Code info
- Model/Catalog Number: VASF105-08. UDI-DI: 10809160451960. Lot Number: 1659384. Expiration Date: 9/30/2027.
- Firm FEI number
- 1047429
- Recalling firm
- AVID Medical, Inc.
- Address 1
- 9000 Westmont Dr
- City
- Toano
- State
- VA
- Postal code
- 23168-9351
- Additional info contact
- Marlene Jones +1-470-2804277
- Reason for recall
- Potential for open seals on header bags, compromising sterility.
- Root cause description
- Process control
- Product quantity
- 108 kits
- Distribution pattern
- U.S Nationwide distributor in the state of Illinois.
- Action
AVID Medical notified consignees on about 09/08/2026 via emailed "URGENT: MEDICAL DEVICE CORRECTION" letter. Consignees were instructed to Segregate, Quarantine, and Inspect all kits identified. If the header bag seal appears to be compromised, discard the entire kit. Consignees were also requested to complete and return the provided Recall Response Form. Distributors were instructed to notify customers if affected kits were further distributed. On 10/06/2026 AVID Medical sent an updated "URGENT: MEDICAL DEVICE CORRECTION" letter to consignees via email. The strategy was updated and consignees were instructed not to use the affected kits and that they should either discard or return them. If returning, they should contact customer service for a Return Goods Authorization. Consignees were again requested to complete and return the provided Recall Response Form. Distributors were again instructed to notify customers if affected kits were further distributed.
- Harmonized identifiers (openFDA)
- Device name
- General Surgery Tray
- Medical specialty description
- General, Plastic Surgery
- Regulation number
- 878.4370
- Device class
- 2
- K number
- K952539, K934028, K951478, K872448, K934428, K892389, K964011, K950574, K930700, K871459, K951149, K920292, K895202, K932220, K914935, K890658, K963443, K874760, K213481, K890570, K883250, K914174, K923600, K880961, K932652, K882684, K873973, K914036, K931820, K935686, K893814, K871873, K964921, K931759, K932217, K931760, K945481, K874439, K925216, K902293 +70 more
- Registration number
- 1030451, 3004111573, 3013600605, 3013502418, 3006540014, 3005841027, 1721686, 3011270181, 3011144486, 2024980, 3007139365, 1644019, 3004122598, 3009750712, 2431166, 1928237, 1055236, 3005391805, 8022032, 3006450239, 3005669815, 3031841433, 3017636737, 3004605321, 3030078769, 3014718111, 1823410, 3019798849, 3009637528, 2000028362, 3014325891, 9611024, 3007289408, 3012595397, 1650907, 3045816902, 1123137, 3035642068, 9611594, 1422634 +126 more
- FEI number
- 1030451, 1000121355, 3004111573, 3013600605, 3013502418, 3006540014, 3002692512, 1721686, 3005841027, 3000718854, 3005596530, 3011270181, 3011144486, 1000514656, 3007139365, 1000306431, 3003040625, 3004122598, 3009750712, 1928237, 3005391805, 1000112877, 1000123297, 3005669815, 3031841433, 3006450239, 3017636737, 3004605321, 3030078769, 1823410, 3019798849, 3003807323, 3009637528, 2000028362, 3014325891, 1000512168, 3007289408, 3012595397, 3045816902, 3002807170 +126 more