10" Smallbore Ext Set w/6-Port NanoClave Manifold recall
10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, Clamp, Rotating Luer.
Why was 10" Smallbore Ext Set w/6-Port NanoClave Manifold recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Item Number AM6100. a. Lot Number 3373756, UDI Number (01) 1 0887709 07066 7 (17) 211201 (30) 50 (10) 3373756, Expiration Date 12/01/2021; b. Lot Number 3423328, UDI Number (01) 1 0887709 07066 7 (17) 211401 (30) 50 (10) 3423328, Expiration Date 04/01/2022; c. Lot Number 3446319, UDI Number (01) 1 0887709 07066 7 (17) 211501 (30) 50 (10) 3446319, Expiration Date 05/01/2022
- Product
- 10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, Clamp, Rotating Luer.
- Recalling firm
- ICU Medical de Mexico, S.A. de C.V.
- Quantity
- 200 pouches
- Distribution
- US distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.
- Recall date
- August 22, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)