REF 011-CH3967 Admin Set w/ClaveTM recall
REF 011-CH3967 Admin Set w/ClaveTM, SpirosTM - Product Usage: provides access for the administration of fluids from a container to a patient s…
Why was REF 011-CH3967 Admin Set w/ClaveTM recalled?
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
REF: 011-CH3967 UDI: (01) 1 0887709 12205 2 (17) 260101 (30) 50 (10) 5125174 Lot Number: 5125174
- Product
- REF 011-CH3967 Admin Set w/ClaveTM, SpirosTM - Product Usage: provides access for the administration of fluids from a container to a patient s…
- Recalling firm
- ICU Medical, Inc.
- Distribution
- Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA and WA. The countries of Belgium, Canada, France, Italy, South Africa, Spain, United Kingdom.
- Recall date
- May 19, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)