Haylard BASIC BIOPSY TRAY; Model/Item Number (Kit): PM415;
AVID Medical, Inc. · Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
Open FDA's page for this record- Cfres ID
- 222420
- Product res number
- Z-3153-2026
- Event date initiated
- 2026-08-10
- Event date posted
- 2026-09-16
- Recall status
- Open, Classified
- Res event number
- 99758
- Product code
- LRO
- Product description
- Haylard BASIC BIOPSY TRAY; Model/Item Number (Kit): PM415;
- 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 470-280-4277
- Reason for recall
- Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
- Root cause description
- Nonconforming Material/Component
- Product quantity
- 240 kits
- Distribution pattern
- Domestic: IL, NC, VA, WY;
- Code info
Model/Item Number (Kit): PM415; UDI-DI: 10809160322154; Kit Lots: 1652485, 1656642, 1667835, 1676219, 1682251, 1691940; Recalled Sodium Chloride Ampule Lot: AB5002, AB4003;
- Action
On August 10, 2026 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: 1. Identify, Segregate, and Quarantine all impacted kits listed. 2. Add warning labels to affected kits to ensure all users are aware of the actions to take prior to use. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. If pre-printed labels are needed, please contact your sales representative. 3. REMOVE AND DISCARD the Sodium Chloride, 0.9%, USP 10 mL Flush ampules prior to use. 4. Customers (end-users): If you have received product from a distributor, please contact the distributor or your sales representative with any questions you may have. 5. Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. 6. Complete the attached Recall Response Form and return.
- Harmonized identifiers (openFDA)
- Device name
- General Surgery Tray
- Medical specialty description
- General, Plastic Surgery
- Regulation number
- 878.4370
- Device class
- 2
- K number
- K895202, K881083, K941846, K930270, K961863, K925216, K871873, K874439, K951149, K910368, K934028, K951478, K041080, K854095, K883250, K932221, K890729, K964921, K871437, K913136, K924468, K934688, K905459, K964011, K874760, K935686, K920292, K890570, K902887, K970187, K963715, K934029, K931844, K931759, K880961, K854292, K931820, K934428, K971061, K963721 +70 more
- Registration number
- 3002806603, 8030672, 1055954, 3010452421, 3007289408, 3045857302, 3008496560, 1921846, 1030451, 1423537, 3011144486, 3006400329, 3018077422, 1644019, 1424263, 2029015, 3011500469, 3011554160, 3004361903, 3005246893, 9680425, 2433012, 9616096, 3043620414, 3013600605, 3012811961, 3009637528, 1121203, 3011270181, 3005997949, 9680357, 1047843, 3017636737, 1055892, 3042480961, 3006450239, 3026197444, 1043214, 3003924117, 3015895045 +123 more
- FEI number
- 3002806603, 3003015552, 3007596547, 3010452421, 3007289408, 3045857302, 3008496560, 1921846, 1030451, 3005596530, 3011144486, 3006400329, 3018077422, 3002902735, 1000112968, 3011500469, 3011554160, 3004361903, 3005246893, 3008875470, 2433012, 3043620414, 3013600605, 3012811961, 3001717360, 3009637528, 3003803331, 3011270181, 3005997949, 1047843, 3017636737, 3042480961, 3006450239, 3026197444, 1043214, 3002807170, 3003924117, 3015895045, 3009203853, 3013298431 +123 more