Zyno Medical Administration Set, Sterile. RX recallZ-2895-2016 · Zyno Medical LLC · initiated Jul 29, 2016
Class II Terminated All recalls posted in September 2016
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 Set potential filter leaking
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-2895-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 29, 2016
- Posted by the FDA
- Sep 27, 2016
- Recalling firm
- Zyno Medical LLC
- Quantity
- 78063 sets
- Product code
- FPA
- FDA submissions
- K132841
- Distribution
- US Nationwide Distribution
Product description
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.
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
14 devices cleared under K132841 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Zyno B2-70072Zyno Medical LLC · Set, Administration, Intravascular1 recall52 reports
- 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
Other products in the same recall event
The FDA groups related products into one recall event (event 74892).
- Z-2893-2016 · TerminatedZyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80071-DF Product Code: A2-80071-DF-120 (Expanded recall) Pro…
- Z-2894-2016 · TerminatedZyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80072-F Product Usage: Zyno Medical Administration Set is a d…
- Z-2896-2016 · TerminatedZyno Medical Administration Set Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: B2-70072-F Product Usage: Zyno Medical Administration Set is a de…
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 18, 2026. Text above is shown as published by the FDA.
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