FDA has not published a risk classification for this recall yet.
- Recall #:
- 98395
- Lot/product code:
- 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, 2024328752, 2024328755, 2024328760, 2024328762, 2024328764, 2024328767, 2024328778, 2024328780, 2024328782, 2024328785, 2024328788, 2024328790, 2024328792, 2024328795, 2024328798, 2024328801, 2024328878, 2024328879, 2024328880, 2024328881, 2024328892, 2024328893, 2024328894, 2024328896, 2024328897, 2024328898, 2024328912, 2024328913, 2024328914, 2024328915, 2024328917, 2024328919, 2024328920, 2024328922, 2024328923, 2024328924, 2024329278, 2024329279, 2024329281, 2024329477, 2024329492, 2024329497, 2024329504, 2024329506, 2024329508, 2024329511, 2024329513, 2024329517, 2024329521, 2024329540, 2024329577, 2024329581, 2024329595, 2024329600, 2024329610, 2024329616, 2024329623, 2024329640, 2024329645, 2024329688, 2024329689, 2024329690, 2024329695, 2024329697, 2024329698, 2024329701, 2024329702, 2024329704, 2024329709, 2024329816, 2024329820, 2024329821, 2024329827, 2024329829, 2024329838, 2024329840, 2024329843, 2024329846, 2024329849, 2024330386, 2024330389, 2024330391, 2024330395, 2024330396, 2024330420, 2024330422, 2024330423, 2024330425, 2024330427, 2024330753, 2024330754, 2024330755, 2024330756, 2024330757, 2024330758, 2024330759, 2024330760, 2024331236, 2024331237, 2024331240, 2024331241, 2024331242, 2024331243, 2024331245, 2024331247, 2024331248, 2024331249, 2024331262, 2024331263, 2024331264, 2024331265, 2024331266, 2024331268, 2024331270, 2024331271, 2024331276, 2024331277, 2024331282, 2024331293, 2024331294, 2024331296, 2024331297, 2024331299, 2024331303, 2024331305, 2024331309, 2024331312, 2024331314, 2024331318, 2024331319, 2024331322, 2024331323, 2024331324, 2024331325, 2024331326, 2024331328, 2024331329, 2024331331, 2024331352, 2024331355, 2024331360, 2024331361, 2024331363, 2024331633, 2024331638, 2024331642, 2024331644, 2024331661, 2024331664, 2024331666, 2024331670, 2024331672, 2024331676, 2024331756, 2024331757, 2024331759, 2024331762, 2024331763, 2024331764, 2024331765, 2024331766, 2024331770, 2024331771, 2024331782, 2024331783, 2024331784, 2024331785, 2024331874, 2024331875, 2024331877, 2024331878, 2024331880, 2024331881, 2024331883, 2024331884, 2024331885, 2024331886, 2024332124, 2024332126, 2024332128, 2024332134, 2024332135, 2024332136, 2024332138, 2024332139, 2024332140, 2024332141, 2024332239, 2024332244, 2024332247, 2024332251, 2024332255, 2024332266, 2024332295, 2024332321, 2024332324, 2024332326, 2024332355, 2024332358, 2024332362, 2024332366, 2024332368, 2024332369, 2024332370, 2024332371, 2024332372, 2024332373, 2024332495, 2024332497, 2024332498, 2024332499, 2024332500, 2024332501, 2024332502, 2024332505, 2024332508, 2024332509, 2024332513, 2024332514, 2024332515, 2024332516, 2024332518, 2024332520, 2024332522, 2024332524, 2024332525, 2024332527, 2024332533, 2024332534, 2024332535, 2024332537, 2024332538, 2024332541, 2024332544, 2024332545, 2024332547, 2024332549, 2024332553, 2024332555, 2024332556, 2024332557, 2024332558, 2024332559, 2024332561, 2024332562, 2024332563, 2024332564, 2024332571, 2024332573, 202433257… (truncated, 345180 characters total — see the official FDA record for the full value)
- Recalling firm:
- Abiomed, Inc.