Zyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y… recallZ-2058-2019 · Zyno Medical LLC · initiated May 29, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Zyno Medical LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-2058-2019
- Status
- Terminated
- Initiated by the company
- May 29, 2019
- Recalling firm
- Zyno Medical LLC
- Quantity
- 354 cases (50/case)=17700
- Product code
- FPA
- FDA submissions
- K132841
- Distribution
- MA
Product description
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
Code information (models, lots, serial numbers)
Lot Numbers:18037128,18065375, 19015969 UDl/UPC/GTIN: 00814371020198
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Zyno B2-70072Zyno Medical LLC · Set, Administration, Intravascular1 recall52 reports
Other devices under the same FDA submission
13 devices cleared under K132841 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Zyno B2-70072-FZyno Medical LLC · Set, Administration, Intravascular1 recall25 reports
- Zyno B2-70071-DFZyno Medical LLC · Set, Administration, Intravascular37 reports
- Zyno A2-80071-DFZyno Medical LLC · Set, Administration, Intravascular28 reports
- Zyno A2-80072Zyno Medical LLC · Set, Administration, Intravascular22 reports
- Zyno B2-70071-DZyno Medical LLC · Set, Administration, Intravascular22 reports
- Zyno B2-70071-DF120Zyno Medical LLC · Set, Administration, Intravascular12 reports
- Zyno A2-80071-DF120Zyno Medical LLC · Set, Administration, Intravascular7 reports
- Zyno A2-80070Zyno Medical LLC · Set, Administration, Intravascular6 reports
- Zyno B2-70070Zyno Medical LLC · Set, Administration, Intravascular5 reports
- Zyno B2-70071-PZyno Medical LLC · Set, Administration, Intravascular5 reports
- Zyno A2-80071-DZyno Medical LLC · Set, Administration, Intravascular4 reports
- Zyno A2-80075Zyno Medical LLC · Set, Administration, Intravascular4 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 83026).
- Z-2059-2019 · TerminatedZyno 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
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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