Z-2813-2018Class II
10" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer
ICU MEDICAL de MEXICO, S. de R.L. de C.V. / initiated 2018-03-01 / Terminated
ICU Medical de Mexico, S.A. de C.V. began a recall of 10" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer on . FDA classified it as Class II and gives the reason as "ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female...". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-2813-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- ICU MEDICAL de MEXICO, S. de R.L. de C.V.
- Product
- 10" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer
- Product code
- FMG Stopcock, I.V. Set
- Reason for recall
- ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
- FDA root cause
- Other
- Action
- ICU Medical notified customers of the recall on about 03/01/2018 via URGENT: Medical Device Recall Notification. The notification informed customers that this was an update and expansion to previously initiated recall. Instructions included to inspect inventory for affected devices, arrange for the return of affected devices, and complete and return the Urgent Medical Device Recall Notification Response Form to [email protected].
- Quantity in commerce
- 650 pouches
- Distribution
- US distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.
- Product codes and lots
- Item Number AM6109. a. Lot Number 3373758, UDI Number (01) 1 0887709 07764 2, Expiration Date 12/01/2021; b. Lot Number 3391364, UDI Number (01) 1 0887709 07764 2 (17) 220101 (30) 50 (10) 3391364, Expiration Date 01/01/2022; c. Lot Number 3511445, UDI Number (01) 1 0887709 07764 2 (17) 220801 (30) 50 (10) 3511445, Expiration Date 08/01/2022
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2797-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2798-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2799-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2800-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2801-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2802-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2803-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2804-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2805-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2806-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2807-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2808-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2809-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2810-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2811-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2812-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2813-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2814-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2815-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2816-2018 | Class II | Terminated | Voluntary: Firm initiated |
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