BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.
FDA Recall Z-1764-2022 · Posted None
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Recalling FirmMaquet Medical Systems USA
Recall StatusOpen, Classified
Product CodeDTZ
Date Initiated2022-07-22
Product Quantity206 US; 48,960 Worldwide
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).
Firm Action
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.
Root Cause
Package design/selection
Distribution Pattern
Worldwide distribution - US Nationwide and the countries Canada and Australia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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