Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011-00 Software Version: N/A Product Description: Mixing Bowl and Spatula Component: N/A

Reason: Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or peeling seals. Compromised sterile barrier may lead to clinically insignificant extension of surgery or infection leading to surgical intervention.

Code information: Lot Code: Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)301014(10)85390029 ; Individual UDI (01)00889024376564(17)301014(10)85390029 ; Lot Number 85390029 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)301103(10)85682882 ; Individual UDI (01)00889024376564(17)301103(10)85682882 ; Lot Number 85682882 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)301001(10)85390028 ; Individual UDI (01)00889024376564(17)301001(10)85390028 ; Lot Number 85390028 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300422(10)82395239 ; Individual UDI (01)00889024376564(17)300422(10)82395239 ; Lot Number 82395239 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300423(10)82395240 ; Individual UDI (01)00889024376564(17)300423(10)82395240 ; Lot Number 82395240 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300929(10)85390027 ; Individual UDI (01)00889024376564(17)300929(10)85390027 ; Lot Number 85390027 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300924(10)85390026 ; Individual UDI (01)00889024376564(17)300924(10)85390026 ; Lot Number 85390026 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300415(10)82395238 ; Individual UDI (01)00889024376564(17)300415(10)82395238 ; Lot Number 82395238 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300922(10)85390025 ; Individual UDI (01)00889024376564(17)300922(10)85390025 ; Lot Number 85390025 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300826(10)85390022 ; Individual UDI (01)00889024376564(17)300826(10)85390022 ; Lot Number 85390022 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300918(10)85390024 ; Individual UDI (01)00889024376564(17)300918(10)85390024 ; Lot Number 85390024 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300722(10)85390023 ; Individual UDI (01)00889024376564(17)300722(10)85390023 ; Lot Number 85390023 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)310122(10)86970970 ; Individual UDI (01)00889024376564(17)310122(10)86970970 ; Lot Number 86970970

Distribution pattern: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, MI, MO, MS, NC, NE, NM, NY, OH, OK, PA, SD, TN, TX, UT, WA, WI and the countries of Canada, Australia, New Zealand, Malaysia, EMEA, Chile.