Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 31, 2019
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
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Zyno Medical LLC recalled Zyno Medical Administration Set -105"ADMIN SET 20DP W/FILTER 2YSITES CLMP- For Use with Z… - a moderate-severity action.
Zyno Medical Administration Set -105"ADMIN SET 20DP W/FILTER 2YSITES CLMP- For Use with Z… was recalled by Zyno Medical LLC in July 31, 2019. Reason: Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administra…. Check the official notice for the remedy. Verify recall #Z-2059-2019 with the FDA Devices before acting.
The recall
Zyno Medical LLC issued this moderate-severity FDA Devices recall-Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administra….
- Moderate
- severity level
- Class II
- classification
- July 31, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2059-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2059-2019) was formally reported on July 31, 2019, with the manufacturer initiating the action on May 29, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Zyno Medical LLC is listed as the recalling firm, operating out of Natick, MA. Federal records list the affected scope as 360 cases (50/case)=18,000.
The documented reason for this recall is: 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,… Distribution data in the federal record shows the product reached: MA. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
360 cases (50/case)=18,000
Related Recalls
6
3 from same agency
Product description
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
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2059-2019 |
| Date reported | July 31, 2019 |
| Date initiated | May 29, 2019 |
| Recalling firm | Zyno Medical LLC |
| Firm location | Natick, MA |
| Affected scope | 360 cases (50/case)=18,000 |
| Distribution | MA |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2059-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Zyno Medical LLC. Units affected: 360 cases (50/case)=18,000.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 31, 2019. Severity: Moderate. Recall number: Z-2059-2019.
Where was the recalled product distributed? ▼
Distribution: MA.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2059-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 31, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.