30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave recall
30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer a single use, sterile, non-pyrogenic device which…
Why was 30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave 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 011-AM3003. a. Lot Number 3303902, UDI Number (01)1 0840519 09277 6 (17)210800 (30) 50 (10) 3303902, Expiration Date 08/01/2021; b. Lot Number 3380550, UDI Number (01) 1 0840619 09277 8 (17) 211201 (30) 50(10) 3380550, Expiration Date 12/01/2021
- Product
- 30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer a single use, sterile, non-pyrogenic device which…
- Recalling firm
- ICU Medical de Mexico, S.A. de C.V.
- Quantity
- 100 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)