Z-2058-2019Class II

Zyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For Use with Zyno Medical Infusion...

Name: Z-2058-2019 Zyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For Use with Zyno Medical Infusion...
Creator: Zyno Medical LLC
Published: 2019-05-29
License: https://open.fda.gov/license/

Zyno Medical LLC. / initiated 2019-05-29 / Terminated / root cause: manufacturing process

FDA source

Zyno Medical LLC began a recall of Zyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code:B2-70072 on 2019-05-29. FDA classified it as Class II and gives the reason as "Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administration set to be pumped to the proximal end of the tubing when secondary set is used with the primary set. Thus...". 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-2058-2019
Classification: Class II
Status: Terminated
Initiated: 2019-05-29
Posted: 2019-07-23
Terminated: 2020-06-22
Recalling firm: Zyno Medical LLC.
Product: Zyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code:B2-70072
Product code: FPA Set, Administration, Intravascular
Reason for recall: Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administration set to be pumped to the proximal end of the tubing when secondary set is used with the primary set. Thus, instead of delivering fluid to the patient, blood may be drawn from the patient if there is space in the drug container to hold extra volume of fluid, under the condition that the reversed pinch clamp is not identified
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On May 29, 2019 Zyno issued letter to the Distributor advising of the problem and health risk and action to take: remove all recalled products with codes, cease use and immediately and return them to Zyno Medical for replacement from unaffected lots. Call or email for instructions on the return of products: (508) 907-7772 (Monday to Friday, 9:30 a.m. to 5 p.m. EST) or [email protected] to acknowledge receiving this recall notice. Zyno issued a follow-up recall letter on 6/10/19 via email to the Distributor to issue to the user/customer level.
Quantity in commerce: 354 cases (50/case)=17700
Distribution: MA
Product codes and lots: Lot Numbers:18037128,18065375, 19015969 UDl/UPC/GTIN: 00814371020198

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2058-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2058-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-23
Z-2059-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-23

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)