REF 20130-01 Spinning Spiros¿ Closed Male Luer recall
REF 20130-01 Spinning Spiros¿ Closed Male Luer, Red Cap REF CH2000S-PC Spinning Spiros¿ Closed Male Luer, Purple Cap - Product Usage: provides access…
Why was REF 20130-01 Spinning Spiros¿ Closed Male Luer 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: 20130-01 CH2000S-PC UDI: (01) 1 0840619 02338 3 (17) 260101 (30) 50 (10) 5125300 (01) 1 0840619 02756 5 (17) 260101 (30) 50 (10) 5125296 Lot Number: 5125300 5125296
- Product
- REF 20130-01 Spinning Spiros¿ Closed Male Luer, Red Cap REF CH2000S-PC Spinning Spiros¿ Closed Male Luer, Purple Cap - Product Usage: provides access…
- 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)