120" (305 cm) 10 Drop Primary Set w/2 MicroClave¿ recall
120" (305 cm) 10 Drop Primary Set w/2 MicroClave¿, Hand Pump, Remv 2 Gang 4-Way Stopcock, Y-Connector, Rotating Luer, 1 Ext, Sterile The blood tubing…
Why was 120" (305 cm) 10 Drop Primary Set w/2 MicroClave¿ recalled?
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
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 Z4089, Lot Number 69-717-SJ, 70-260-SL, 73-197-HE, 74-725-JW
- Product
- 120" (305 cm) 10 Drop Primary Set w/2 MicroClave¿, Hand Pump, Remv 2 Gang 4-Way Stopcock, Y-Connector, Rotating Luer, 1 Ext, Sterile The blood tubing…
- Recalling firm
- ICU Medical, Inc.
- Quantity
- 160,016 units total
- Distribution
- Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.
- Recall date
- August 15, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)