| Date Initiated by Firm | May 29, 2019 |
|---|
| Create Date | July 23, 2019 |
|---|
| Recall Status1 |
Terminated 3 on June 22, 2020 |
| Recall Number | Z-2058-2019 |
|---|
| Recall Event ID |
83026 |
| 510(K)Number | K132841 |
|---|
| Product Classification |
Set, administration, intravascular - Product Code FPA
|
| 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 |
|---|
| Code Information |
Lot Numbers:18037128,18065375, 19015969 UDl/UPC/GTIN: 00814371020198 |
Recalling Firm/
Manufacturer |
Zyno Medical LLC
177 Pine St
Natick MA 01760-1331
|
| For Additional Information Contact | SAME
508-650-2008 |
|---|
Manufacturer 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 |
|---|
FDA Determined
Cause 2 | 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 in Commerce | 354 cases (50/case)=17700 |
|---|
| Distribution | MA |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = FPA
|
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