Terumo TenderFlow Pediatric Venous Cannulae recall: Particulate Matter
Terumo TenderFlow Pediatric Venous Cannulae, 8, 10, 12, 14, 16, 18, 20, 22 & 24 Fr angled & straight tip, 1/4" & 3/8" flare, Product Usage: Venous…
Why was Terumo TenderFlow Pediatric Venous Cannulae recalled?
During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
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?
Part No. 813542, Lot #: AM000378; Part No. 813541, Lot #: AM002689; Part No. 813544, Lot #: AM006016, AM017817; Part No. 813546, Lot #: AM002709, AM006018, AM006048, AM017262; Part No. 813545, Lot #: AM002705, AM006046, AM007636; Part No. 813548, Lot #: AM002707, AM006050, AM017681; Part No. 813547, Lot #: AM002697, AM006020, AM007724; Part No. 813550, Lot #: AM001312, AM004268, AM007732, AM018316; Part No. 813549, Lot #: AM002717, AM006052, AM007637; Part No. 813552, Lot #: AM003778, AM007725; Part No. 813554, Lot #: AM001309; Part No. 813551, Lot #: AM002702, AM007635; Part No. 813553, Lot #: AM002708; Part No. 813556, Lot #: AM007733; Part No. 813555, Lot #: AM002719; Part No. 813557, Lot #: AM007726; Part No. 813560, Lot #: AM018160; Part No. 813559, Lot #: AM008235; Part No. 813561, Lot #: AM007639; Part No. 813566, Lot #: AM004227, AM017924 & Part No. 813565, Lot #: AM001315, AM006072.
- Product
- Terumo TenderFlow Pediatric Venous Cannulae, 8, 10, 12, 14, 16, 18, 20, 22 & 24 Fr angled & straight tip, 1/4" & 3/8" flare, Product Usage: Venous…
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Quantity
- 14,380 units
- Distribution
- Worldwide Distribution - US (nationwide) in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY and the countries of : Australia, Belgium, Canada, Chile, Japan, Malaysia, Mexico, Singapore, Taiwan, Thailand, United Arab Emirates (UAE) & United Kingdom.
- Recall date
- July 30, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)