Increased risk of purge leaks with Generation 1 purge cassettes.
Reason for recall: Increased risk of purge leaks with Generation 1 purge cassettes. Distribution: Worldwide distribution. Quantity: 33,107 units Lot/code info: 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, 20243176
00813502011135, 00813502011029, 00813502010510, 00813502011999, 00813502010947, 04260113630273, 04260113630242, 00813502011777, 04260113630280
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.