DUO FLOW CUSTOM TRAYS; TRAY #414 TRAY #415 TRAY #67
FDA Recall Z-2941-2018 · Posted None
Recalling FirmMedical Components, Inc dba MedComp
Recall StatusTerminated
Product CodeMPB
Date Initiated2018-07-12
Date Terminated2020-07-02
Reason for Recall
The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death.
Firm Action
On July 12, 2018, the firm sent a Product Recall letter to its customers. Customers were provided with a full list of product codes and lot numbers and informed that those items had been recalled due to a potential for the suture wings to crack or break.
Customers were informed that implanted catheters with intact suture wings do not need to be removed. However, an alternative method of catheter securement should be initiated for all implanted catheters, due to the potential for the suture wings to crack or break.
Customers were instructed to return all unused recalled product to Medcomp. If product was further distributed, customers were asked to notify their sub-accounts.
Contact your customer service representative for a Returned Goods Authorization (RGA)
number if necessary. The phone number to call is 215-256-4201. Customers are asked to complete and return a customer response form included with the recall letter by fax (215-256-9191) or email ([email protected]).
Root Cause
Process control
Distribution Pattern
Nationwide distribution; worldwide distribution.
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.