Z-2804-2018Class II
28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave Manifold, Check Valve, 2 NanoClave, 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 28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave Manifold, Check Valve, 2 NanoClave, 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-2804-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- ICU MEDICAL de MEXICO, S. de R.L. de C.V.
- Product
- 28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave Manifold, Check Valve, 2 NanoClave, 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
- 74 pouches
- Distribution
- US distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.
- Product codes and lots
- Item Number 011-AM6116. a. Lot Number 3380551, UDI Number (01) 1 0840619 09274 7 (17) 211201 (30) 50 (10) 3380551, Expiration Date 12/01/2021; b. Lot Number 3493462, UDI Number (01) 1 0840619 09274 7 (17) 220701 (30) 50 (10) 3493482, Expiration Date 07/01/2022
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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