United StatesPurge Cassette components sold within Impella pump sets and individually packaged — identifiable by product codes such as 0043-0003, 0043-0002, 004334, 004413, 0046-0011, 0048-0002 and many related GTINs and batch numbers — are affected. They were recalled due to an increased risk of purge leaks with Generation 1 purge cassettes. The recall covers worldwide distribution of 33,107 units.
What's being recalled
Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes. 1. Purge Cassette, 5 Pack; Product Code: 0043-0003. 2. Impella RP US Pump Set; Product Code: 004334. 3. Purge Cassette, Packaged; Product Code: 0043-0002. Also included inside Product Code 0043-0003 above. Product Code 0043-0002 also includes innermost packaged product with Product Code 0043-0001. 4. Impella 2.5 Set; Product Code: 004413 (Customer facing code 005040). 5. Impella RP Pump Set, EU; Product Code: 0046-0011. 6. Impella CP Pump Set, EU; Product Code: 0048-0002. 7. Impella CP Pump Set BR; Product Code: 0048-0002-BR. 8.…
Recalling firm: Abiomed, Inc., Danvers, MA, United States.
How to identify it
1. Product Code: 0043-0003. GTIN: 00813502011135. All Purge Cassette batches/lot numbers are affected. 2. Product Code: 004334. GTIN: 00813502011029. All Purge Cassette batches/lot numbers are affected. 3. Product Code: 0043-0002. GTIN: 00813502010510. All Purge Cassette batches/lot numbers are affected. Also included inside Product Code 0043-0003 above. Product Code 0043-0002 also includes innermost packaged product with Product Code 0043-0001 (GTIN: 00813502011999). 4. Product Code: 004413 (Customer facing code 005040). GTIN: 00813502010947. All Purge Cassette batches/lot numbers are affected. 5. Product Code: 0046-0011. GTIN: 04260113630273. All Purge Cassette batches/lot numbers are affected. 6. Product Code: 0048-0002. GTIN: 04260113630242. All Purge Cassette batches/lot numbers are affected. 7. Product Code: 0048-0002-BR. GTIN: 00813502011777. All Purge Cassette batches/lot numbers are affected. 8. Product Code: 0048-0014 (Also inclusive of codes 0048-0047 and 1000402 listed below). GTIN: 04260113630280. All Purge Cassette batches/lot numbers are affected. Finished Good Batch Numbers: 2024309080, 2024309083, 2024309085, 2024309088, 2024309091, 2024309095, 2024309099, 2024309104, 2024309109, 2024309112, 2024309333, 2024309335, 2024309339, 2024309343, 2024309346, 2024309347, 2024309349, 2024309350, 2024309351, 2024309355, 2024310812, 2024310813, 2024310815, 2024310817, 2024310818, 2024310819, 2024310823, 2024310824, 2024310825, 2024310826, 2024317648, 2024317649, 2024317650, 2024317651, 2024317652, 2024317653, 2024317654, 2024317655, 2024317657, 2024317660, 2024324585, 2024324587, 2024324588, 2024324589, 2024324591, 2024324592, 2024324593, 2024324594, 2024324595, 2024324596, 2024328613, 2024328619, 2024328620, 2024328622, 2024328625, 2024328629, 2024328634, 2024328636, 2024328640, 2024328641, 2024328666, 2024328670, 2024328675, 2024328692, 2024328706, 2024328716, 2024328718, 2024328720, 2024328722, 2024328723, 2024328737, 2024328741, 2024328743, 2024328749…
The hazard
Increased risk of purge leaks with Generation 1 purge cassettes.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide distribution.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)