Recall Z-1767-2022
Maquet Medical Systems USA · initiated July 22, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70106.9078. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.
Codes / lots: UDI-DI: 04058863080383 Lots 3000190535, 3000190536, 3000190537, 3000192076, 3000192077, 3000192078, 3000192079, 3000193358, 3000193359, 3000193360, 3000193361, 3000193362, 3000195061, 3000195062, 3000195063, 3000195064, 3000195065, 3000195066, 3000195067, 3000196193, 3000196195, 3000196196, 3000196197, 3000196198, 3000196199, 3000197830, 3000197831, 3000197833, 3000197837, 3000197839, 3000199069, 3000199071, 3000199072, 3000199073, 3000199074, 3000199077, 3000200108, 3000200110, 3000200111, 3000200112, 3000200113, 3000202025, 3000202027, 3000202029, 3000202030, 3000202031, 3000203092, 3000203093, 3000204058, 3000204156, 3000204157, 3000204284, 3000205878, 3000205879, 3000205880, 3000207510, 3000208687, 3000208692, 3000210629, 3000210630, 3000215200, 3000215238, 3000216174, 3000216177, 3000220057, 3000220062, 3000221755, 3000221756, 3000221757, 3000224126, 3000224134, 3000227577, 3000227580, 3000228336, 3000228337, 3000228338, 3000228804, 3000228805, 3000228864, 3000232543, 3000234522
Reason for recall
The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020).
FDA-determined cause: Package design/selection
Action taken
On July 15, 2022, the firm notified affected customers via Urgent Medical Device Removal Expansion letter. The letter informed customers of the inclusion of additional product codes and lots into the earlier recall initiated on November 6, 2020. Customers were instructed to examine their inventory and identify any affected product on hand. Affected product in use may be continued to be used according to normal practices. Unused and unexpired affected product should be immediately returned to Getinge for credit. Please contact Getinge Customer Service at (888) 9GETUSA / (888) 943-8872 (press option 2) between the hours of 8:00 a.m. and 6:00 p.m. Eastern Standard Time to request a return authorization (RMA) and shipping instructions to return any affected product. At this time, the recalling firm has already implemented the more durable Tyvek accessory packaging in all product manufactured September 2021 and later.
Details
- Recall number
- Z-1767-2022
- Initiated
- July 22, 2022
- Product code
- DTZ – Oxygenator, Cardiopulmonary Bypass
- Quantity
- 6,871 US; 18,670 worldwide
- Distribution
- Worldwide distribution - US Nationwide and the countries Canada and Australia.
- Recalling firm
- Maquet Medical Systems USA, Wayne, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1764-2022 Class II | BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A preconnected set used for…The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility… | 07/22/2022Open, Classified |
| Z-1765-2022 Class II | BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70105.2797. A preconnected set used for…The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility… | 07/22/2022Open, Classified |
| Z-1766-2022 Class II | BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70106.9077. A preconnected set used for…The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility… | 07/22/2022Open, Classified |