Recall Z-1418-2023 ยท MND Ligator, Esophageal
Olympus Corporation of the Americas
Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip Model HX 201UR 135 - Rotatable, 230 cm long, 2.8 scope channel, standard clip Model HX 201UR 135L - Rotatable, 230 cm long, 2.8 mm scope channel, Long clip
| Date | Apr 20, 2023 (initiated Feb 23, 2023) |
| Status | Open, Classified |
| Reason | There have been complaints that the clip did not come out of the tube sheath during the procedure. |
| Root cause | Process change control |
| Action | The firm, Olympus, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated 2/23/2023 to its customers. The letter described the product, the issue and actions to be taken. The customers were instructed to do the following: 1) immediately assess, cease use of and quarantine any affected (lot numbers) products you have identified. 2.) Call your Olympus customer service representative at 1-800-848-9024, option 2 to receive a RMA to return any affected product at not charge. 3.)Access the Olympus recall portal to indicate that you have received this notification at https://olympusamerica.com/recall. |
| Quantity | 65.9 boxes (373 pieces) |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013066 | HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE Olympus America, Inc., Dec 11, 2001 |