Device product
Sterile Procedural Trays, labeled as the following: a. RHINOPLASTY PACK b. OSC OTOLOGY PACK-LF c. RHYZOTOMY
Z-1071-2023
Product summary
- Event
- Event 91386
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 86 cases (152 units)
- Official record key
device-enforcement:Z-1071-2023
Official wording
Reason: Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Code information: a. RHINOPLASTY PACK, Item Number: DYNJ27333F, Case UDI/GTIN: 40888277055293, Unit UDI/GTIN: 10888277055292, Lot Number: 22JMD960; b. OSC OTOLOGY PACK-LF, Item Number: DYNJ37384D, Case UDI/GTIN: 40193489306898, Unit UDI/GTIN: 10193489306897, Lot Number: 22HBY172; c. RHYZOTOMY, Item Number: DYNJ902288G, Case UDI/GTIN: 40193489885126, Unit UDI/GTIN: 10193489885125, Lot Number: 22JBU356,22JBT657;
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Derived failure modes
-
Unknown
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.