Recall Z-1474-2022 ยท LRO General Surgery Tray
MEDLINE INDUSTRIES, LP - SPT
Medline Convenience kits labeled as: a. MAJOR VASCULAR CDS, b. POST OP KIT, c. KIT NEURO FUS LUM POST SANSUR, d. KIT NEURO FUS LUM POST SANSUR , e. PRE-OP ACCESSORY KIT CHOICE, f. DEEP BRAIN STIMULATION PACK, g. DEEP BRAIN STIMULATION PACK, h. MINIMALLY INVASIVE PACK-LF, i. EVLP Pack/Kit, j. GENERAL PURPOSE CV, k. GENERAL PURPOSE CV, l. KIT GERMANTOWN CABG, m. KIT GERMANTOWN CABG, n. DENTAL RESTO
| Date | Jun 6, 2022 |
| Status | Open, Classified |
| Reason | Kits contain leaking bottles of isopropyl alcohol |
| Root cause | Under Investigation by firm |
| Action | The firm's consignees were notified by US mail on 06/06/2022 and instructed to destroy any affected kits on hand in accordance with their local and state regulations. |
| Quantity | 6569 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.