FDA Medical Device Recalls (openFDA)
Zyno Medical LLC: Zyno Medical Administration Set -105"ADMIN SET 20DP W/FILTER 2YSITES CLMP- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code: B2-70072-F
- Recall number
- Z-2059-2019
- Recalling firm
- Zyno Medical LLC
- Product
- Zyno Medical Administration Set -105"ADMIN SET 20DP W/FILTER 2YSITES CLMP- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code: B2-70072-F
- Status
- Terminated
- Initiated
- 2019-05-29
- Posted
- not on file
- Terminated
- 2020-06-22
- Reason
- 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
- 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 wagner.Cruz@zvnomed.com 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
- 360 cases (50/case)=18,000
- Distribution
- MA
- Lot, serial or model codes
- Lot Numbers: 18046309, 18026344 UDl/UPC/GTIN: 00814371020204
- 510(k) numbers
- ["K132841"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 3006575795
- Firm city
- Natick
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28