PlainRecordsFDA · Medical device recall
Surgicare Neuro Pack… and 4 more products
- Date
- April 13, 2022
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Ongoing
- Filed by
- Stradis Medical, LLC dba Stradis Healthcare
- Reason
- The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
- Distribution pattern
- US Nationwide distribution in the states of IN, TX, and PA.
5 products in this recall
Surgicare Neuro Pack…
- Product
- Surgicare Neuro Pack - Neurological Kit
- Quantity
- 176 units
- Codes and lots
- SKU/Part Number 570-2224; UDI H65257022240 Lot Numbers: 20143461101, 20156461682, 20217462972, 20309467143, 20343467142, 20364467508, 20364468264, 21076471300, 21082471463, 21102472013, 21117472929, 21126473545
- Recall started
- Feb. 25, 2022
- Device type
- Neurological Tray
- Root cause (FDA)
- Process change control
- What the company told customers
- A copy of the final recall letter was sent to all affected consignees via 1st class USPS mail on February 25, 2022. The consignees were instructed that the use of further distribution of the potentially perforated kits should immediately cease. Instructions were provided to return any unused Surgical Kits with the scope of this recall to Stradis Healthcare s facility in Georgia. Periodic effectiveness checks will be conducted in order to follow-up with consignees to ensure effectiveness.
- Recall number
- Z-0862-2022
Lum Lam Custom Pack…
- Product
- Lum Lam Custom Pack - Anesthesia Kit
- Quantity
- 21 units
- Codes and lots
- SKU/Part Number 570-2674; UDI H65257026741 Lot Numbers: 21300478831 and 21314479685
- Recall started
- Feb. 25, 2022
- Device type
- Anesthesia Kit
- Root cause (FDA)
- Process change control
- What the company told customers
- A copy of the final recall letter was sent to all affected consignees via 1st class USPS mail on February 25, 2022. The consignees were instructed that the use of further distribution of the potentially perforated kits should immediately cease. Instructions were provided to return any unused Surgical Kits with the scope of this recall to Stradis Healthcare s facility in Georgia. Periodic effectiveness checks will be conducted in order to follow-up with consignees to ensure effectiveness.
- Recall number
- Z-0863-2022
Total Knee Pack…
- Product
- Total Knee Pack - Surgical Kit
- Quantity
- 76 units
- Codes and lots
- SKU/Part Number 570-2676; UDI H65257026760 Lot Numbers: 20156461673, 20171461909, 20174462304, 20239463246, 20342468026, 21130473544, 21286478854, 21326479944, 22005482064
- Recall started
- Feb. 25, 2022
- Device type
- Orthopedic Tray
- Root cause (FDA)
- Process change control
- What the company told customers
- A copy of the final recall letter was sent to all affected consignees via 1st class USPS mail on February 25, 2022. The consignees were instructed that the use of further distribution of the potentially perforated kits should immediately cease. Instructions were provided to return any unused Surgical Kits with the scope of this recall to Stradis Healthcare s facility in Georgia. Periodic effectiveness checks will be conducted in order to follow-up with consignees to ensure effectiveness.
- Recall number
- Z-0864-2022
Anterior Hip Pack…
- Product
- Anterior Hip Pack - Surgical Kit
- Quantity
- 100 units
- Codes and lots
- SKU/Part Number 570-2677; UDI H65257026770 Lot Numbers: 20170461910, 20163461674, 20170462303, 20219463245, 20238464203, 20268464581, 21082472172, 21110472562, 21138473542, 21167474498, 21287478853, 21167474498, 21349479943
- Recall started
- Feb. 25, 2022
- Device type
- Orthopedic Tray
- Root cause (FDA)
- Process change control
- What the company told customers
- A copy of the final recall letter was sent to all affected consignees via 1st class USPS mail on February 25, 2022. The consignees were instructed that the use of further distribution of the potentially perforated kits should immediately cease. Instructions were provided to return any unused Surgical Kits with the scope of this recall to Stradis Healthcare s facility in Georgia. Periodic effectiveness checks will be conducted in order to follow-up with consignees to ensure effectiveness.
- Recall number
- Z-0865-2022
Coryell Memorial Hosp Total…
- Product
- Coryell Memorial Hosp Total, Joint Pack - Surgical Kit
- Quantity
- 348 units
- Codes and lots
- SKU/Part Number 690-260; UDI M7526902600 Lot Numbers: 1912331779, 1914333072, 1915433813, 1915634371, 1919334769, 1923436351, 1930338689, 1935342884, 2006644326, 2007745836, 20149461110, 20241463865, 20303466242, 20328467437, 20356468152, 21033468960, 21050471039, 21270476822
- Recall started
- Feb. 25, 2022
- Device type
- Orthopedic Tray
- Root cause (FDA)
- Process change control
- What the company told customers
- A copy of the final recall letter was sent to all affected consignees via 1st class USPS mail on February 25, 2022. The consignees were instructed that the use of further distribution of the potentially perforated kits should immediately cease. Instructions were provided to return any unused Surgical Kits with the scope of this recall to Stradis Healthcare s facility in Georgia. Periodic effectiveness checks will be conducted in order to follow-up with consignees to ensure effectiveness.
- Recall number
- Z-0866-2022
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-0862-2022, Z-0863-2022, Z-0864-2022, Z-0865-2022, Z-0866-2022. The agency record governs; check it and the company before acting.