Z-1474-2015Class II
7" Standard Bore High Pressure Ext Set
Vygon Mfg / initiated 2015-01-15 / Terminated / root cause: manufacturing process
Churchill Medical Systems, Inc. began a recall of 7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer medical fluids on . FDA classified it as Class II and gives the reason as "Potential for leaking caused by insufficient bond between needleless device and female luer". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1474-2015
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Vygon Mfg
- Product
- 7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer medical fluids
- Product code
- FPA Set, Administration, Intravascular
- Reason for recall
- Potential for leaking caused by insufficient bond between needleless device and female luer.
- Root cause tag
- manufacturing process
- FDA root cause
- Process design
- Action
- Vygon sent an Urgent Medical Device Recall letter dated January 15, 2015, to all affected customers via email or courier service. The letter instructs consignees to check stock for products included in the scope of the recall, count and document the affected inventory on the "Recall Acknowledgement and Inventory Return Form" and fax or email the form to Vygon. Vygon customer service will then contact the customer to issue a Return Merchandise Authorization Number so the inventory can be replaced at no cost. Distributors were provided with instructions on how to handle product that was further distributed by them. If after 30-days, product is not returned from each consignee, Vygon will follow-up with the consignee to obtain a status of the product return. Customers with questions were instructed to contact Vygon Customer Service at 1-800-473-5414, or by e-mail at [email protected].
- Quantity in commerce
- 6850
- Distribution
- Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.
- Product codes and lots
- 1311028 1311040 1311041 1407066 1407197 1408055 1409055D 1410048D 1410157D
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1467-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1468-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1469-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1470-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1471-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1472-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1473-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1474-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1475-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1476-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1477-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1478-2015 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.