Recall Z-0566-2022 ยท KNT Tubes, Gastrointestinal (And Accessories)
Avanos Medical, Inc.
MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL
| Date | Dec 22, 2021 |
| Status | Terminated |
| Reason | The External Retention Bolster contained in the kit may be a larger diameter than the tube. |
| Root cause | Under Investigation by firm |
| Action | All USA Distributors and healthcare facilities that were directly shipped impacted devices were sent a Product Advisory Notice beginning on December 22, 2021 by email. Clinical Consignees were instructed to evaluate their facilities inventory of products to determine if any of the impacted product codes were present in their facility. The letter provided information identifying the affected product. It was indicated to segregate and return impacted product. The clinician may recognize that the External Retention Bolster is too large for the accompanying PEG tube when initially use the produ |
| Quantity | 692 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada and Chile. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K924065 | MIC PEG TUBE Medical Innovations Corp., Feb 17, 1994 |