Z-2895-2016Class II

Zyno Medical Administration Set, Sterile. RX For Use with Zyno Medical Infusion Pumps or Gravity Feed

Name: Z-2895-2016 Zyno Medical Administration Set, Sterile. RX For Use with Zyno Medical Infusion Pumps or Gravity Feed
Creator: Zyno Medical LLC
Published: 2016-07-29
License: https://open.fda.gov/license/

Zyno Medical LLC. / initiated 2016-07-29 / Terminated / root cause: manufacturing process

FDA source

Zyno Medical LLC began a recall of 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... on 2016-07-29. FDA classified it as Class II and gives the reason as "Administration Set potential filter leaking". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2895-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-29
Posted: 2016-09-27
Terminated: 2017-07-11
Recalling firm: Zyno Medical LLC.
Product: 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.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Administration Set potential filter leaking
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 78063 sets
Distribution: US Nationwide Distribution
Product codes and lots: B2-70071-DF Lot Codes: 14015279 14026620 14046841 14055191 14055786 14056225 14085743 14085742 15035297 15045941 15045940 15046600 15075275 15075835 15076761 15085107 15086621 15095200 15095647 15097179 15105595 B2-70071-DF-120 lot codes: 15066912 15075253 15075990 15076261 15076304

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2895-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2893-2016	Class II	Terminated	Voluntary: Firm initiated	2016-10-05	2016-09-27
Z-2894-2016	Class II	Terminated	Voluntary: Firm initiated	2016-10-05	2016-09-27
Z-2895-2016	Class II	Terminated	Voluntary: Firm initiated	2016-10-05	2016-09-27
Z-2896-2016	Class II	Terminated	Voluntary: Firm initiated	2016-10-05	2016-09-27

Product code FPA

K132841Class IIZyno Medical Administration SetZyno Medical, LLC / cleared 2014-01-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)