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Terminated

Zyno Medical Administration Set, Sterile. RX For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: B2-70071-DF Product Code: B2-70071-DF-120 (expanded recall) Product Usage: Zyno Medical Administration Set is a device used to administer fluids from a container to a patients vascular system through a needle or a catheter inserted into a vein.

FDA Recall Z-2895-2016 · Posted 2016-09-27

Recalling FirmZyno Medical LLC
Recall StatusTerminated
Product CodeFPA
Date Initiated2016-07-29
Date Terminated2017-07-11
Product Quantity78063 sets

Reason for Recall

Administration Set potential filter leaking

Firm Action

Zyno issued Recall letter dated July 26th, 2016 to affected customers. Customers who received affected products were contacted between 7/29/2016 and 8/1/2016. Customers were asked to return unused product for replacement. For questions contact Customer Service Representative, at 508-907-7796, or [email protected]. Expanded Recall: Two recall letters issued on 11/3/2016 to address the newly identified lots. One letter for customers who received the initial recall letter and the other letter for newly affected customers who did not receive the initial recall letter.

Root Cause

Process control

Distribution Pattern

US Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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