Device product
84" (213 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Cylindrical Hand Pump, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.
Z-2623-2018
Product summary
- Event
- Event 80427
- Status
- Terminated
- Classification
- Class II
- Quantity
- 160,016 units total
- Official record key
device-enforcement:Z-2623-2018
Official wording
Reason: Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Code information: Item Number B9282, Lot Number 3331696, 3343698, 3344218, 3356703, 3367358, 3379230, 3381358, 3387630, 3391913, 3401825, 3416492, 3416493, 3423450, 3429635
Distribution pattern: 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.
Derived failure modes
-
Unknown
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.