Zyno Medical Administration Sets Recalled Due to Inverted Pinch Clamp Defect
Zyno Medical LLC is recalling administration sets with inverted pinch clamps that may cause blood to be drawn from patients instead of delivering fluid.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a significant injury risk where blood may be drawn from the patient instead of delivering fluid, meeting the criteria for a Severe rating.
Plain-English summary
Zyno Medical LLC is recalling Zyno Medical Administration Sets (Product Code: B2-70072) due to a manufacturing defect involving inverted pinch clamps. The recall covers 354 cases (17,700 units) distributed in Massachusetts. Affected lot numbers are 18037128, 18065375, and 19015969.
The defect causes fluid from the distal end of the administration set to be pumped to the proximal end when a secondary set is used with a primary set. If the inverted pinch clamp is not identified, blood may be drawn from the patient instead of delivering fluid, provided there is space in the drug container to hold the extra volume.
Healthcare providers and facilities should stop using the affected administration sets immediately and contact Zyno Medical LLC for instructions on return or replacement. Patients who have received infusions using these sets should consult their healthcare provider if they have concerns.
The recalled product
- 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
- Manufacturer
- Zyno Medical LLC
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot Numbers:18037128
- 18065375
- 19015969 UDl/UPC/GTIN: 00814371020198
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Zyno Medical LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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