5" (13 cm) Smallbore Ext Set w/MicroClave¿ recall
5" (13 cm) Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B99066, Sterile, Rx. The firm name on…
Why was 5" (13 cm) Smallbore Ext Set w/MicroClave¿ recalled?
The infusion sets were manufactured with an incorrect spin collar.
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?
Lot number 3549002, UDI 01) 0 0887709 01857 0 (17) 221001 (30) 01 (10) 3549002.
- Product
- 5" (13 cm) Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B99066, Sterile, Rx. The firm name on…
- Recalling firm
- ICU Medical, Inc.
- Quantity
- 100 pouches
- Distribution
- Worldwide Distribution: US (nationwide) to state in AZ, CA, CO, FL, SC, and TX; and countries of: Canada and Japan.
- Recall date
- April 18, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)