Recall Z-0168-2024 ยท CCW Laryngoscope, Rigid
Covidien
McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
| Date | Nov 1, 2023 (initiated Aug 10, 2023) |
| Status | Open, Classified |
| Reason | Laryngoscope blades may contain an ineffective application of anti-fog agent which may result in condensation accumulating causing the screen to be blurred or obscured. |
| Root cause | Under Investigation by firm |
| Action | On August 10, 2023 Medtronic ( Parent company of Covidien) issued an Urgent via UPS. Medtronic ask consignees to take the following actions: 1. Quarantine all unused product from the affected lots of McGRATH MAC 2 disposable laryngoscope blades. See attachment A for guidance on identifying potentially affected devices. 2. Return all unused product from the affected lots in your inventory to Medtronic as described on the Customer Confirmation Form. 3. Please complete and return the enclosed Customer Confirmation Form even if you do not have unused inventory. 4. Pass on this notice to all th |
| Quantity | 42,367 |
| Distribution | US: AK AL AR AZ CA CO CT DE FL GA IA IL IN KS LA MA MD MI MO MT NC ND NH NJ NM NY OH OK OR PA SD TN TX UT VA WA WI WY OUS: Australia Austria Azerbaijan Bahamas Belgium Croatia Czech Republic Denmark Finland France French Guiana Germany Guadeloupe Hong Kong Hungary Ireland Israel Italy Kazakhstan Ko |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.