Recall Z-0446-2016
Edwards Lifesciences, LLC · initiated November 13, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Intravascular (IV) Administration Sets, Model No. 54IV12, 54IV22, 54IV32, MK2450, 54IV42, MK132, MK2156, MK2270, MK2292, MK2300, MK2374, MK2394, MK2508, MK2227
Codes / lots: 59963616 59963616 59963616 59963616 59963616 59963616 59963616 59963616 59963616 59963616 60062124 59736951 59682161 59682161 59727259 59727259 59727259 59391951 59391951 59391951 59391951 59391951 59407670 59407670 59407670 59407670 59407670 59407670 59407670 59464977 59464977 59464977 59464977 59464977 59464977 59474664 59474664 59474664 59474664 59481176 59481176 59523673 59523673 59523673 59523673 59523673 59540977 59540977 59540977 59540977 59540977 59566031 59566031 59566031 59566031 59566031 59579648 59579648 59579648 59579648 59612801 59612801 59612801 59612801 59612801 59642070 59642070 59642070 59642070 59642070 59752540 59752540 59752540 59752540 59752541 59752541 59752541 59752541 59752541 59752541 59752542 59752542 59752542 59752542 59752542 59766776 59766776 59766776 59766776 59800860 59800860 59800860 59800860 59853819 59853819 59853819 59853819 59876072 59876072 59876072 59876072 59876072 59918517 59918517 59918517 59918517 59923159 59923159 59923159 59923159 59976190 59976190 59976190 59976190 60001498 60001498 60001498 60001498 60001498 60036774 60036774 60036774 60036774 60067981 60067981 60067981 60067981 60090227 60090227 60090227 60090227 60130963 60169135…
Reason for recall
Edward Lifesciences is recalling Intravascular (IV) Administration Sets due to the requirement of an additional FDA submission to support commercialization (clearance) of the devices.
FDA-determined cause: Under Investigation by firm
Action taken
An urgent product notification letter dated 11/13/15 was to customers to inform them that during an internal documentation review, the requirement of an additional FDA submission to support commercialization (clearance) of the devices was discovered. Customers are informed that the Edwards Lifesciences Intravascular (IV) Administration sets are temporarily unavailable for sale. Customers are informed that there is no increased risk to the patients' health or safety by using products in their current inventory and there is no impact to the IV sets included in pressure monitoring kits (with TruWave pressure transducer or VAMP system). Customers are informed that if they are in need of a substitute IV set, then to call customer service at (800) 424-3278. Customers instructed to respond to the customer response form by faxing it to (800) 422-9329.
Details
- Recall number
- Z-0446-2016
- Initiated
- November 13, 2015
- Terminated
- July 15, 2016
- Product code
- DXO – Transducer, Pressure, Catheter Tip
- Quantity
- 147,350 units
- Distribution
- US
- Recalling firm
- Edwards Lifesciences, LLC, Irvine, CA