What's being recalled
DAVINCI TRUCUSTOM BUNDLE; Model/Item Number (Kit): 1. SAMM064-27, 2. SAMM064-28;
GYN LAPAROSCOPY/LAPAROTOMY; Model/Item Number (Kit): 1. WRNM002-15, 2. FBCH108-03;
ADULT HEART TRAY SHANDS JACKS; Model/Item Number (Kit): SHND419-08;
ENDOVASCULAR PACK; Model/Item Number (Kit): VAPX014-04;
CRANIOTOMY PACK; Model/Item Number (Kit): WRNM035-20;
PACK OPEN HEART CFH; Model/Item Number (Kit): 1. UFCF004-06, 2. UFCF004-07;
ROBOTIC PROSTATECTOMY PACK; Model/Item Number (Kit): NAMC423-11;
LAPAROSCOPIC PROSTATECTOMY; Model/Item Number (Kit): NIHB0036-07;
PLASTICS TRAY; Model/Item Number (Kit): EURO053;
DAVINCI LAP/GYN; Model/Item Number (Kit): WRNM037-16;
HEART PREP TRAY; Model/Item Number (Kit): MECV97W;
UROLOGY MAJOR; Model/Item Number (Kit): WRNM058-10;
MAJOR PACK; Model/Item Number (Kit): NIHB0018-11;
GYN LAPAROSCOPY PACK; Model/Item Number (Kit): NAMC436-12;
ABD HYSTERECTOMY; Model/Item Number (Kit): NAMC438-07;
Recalling firm: AVID Medical, Inc., Toano, VA, United States.
How to identify it
1. Model/Item Number (Kit): SAMM064-27; UDI-DI: 10809160439708; Kit Lot Numbers: 1657586, 1658104, 1671251; 2. Model/Item Number (Kit): SAMM064-28; UDI-DI: 10809160516201; Kit Lot Numbers: 1698700; Recalled Supplier Component (in kit): A303416A; Recalled Supplier Lot Number (in kit): NGKU1749, NGKV0359; 1. Model/Item Number (Kit): WRNM002-15; UDI-DI: 10809160487181; Kit Lot Numbers: 1666722; 2. Model/Item Number (Kit): FBCH108-03; UDI-DI: 10809160399781; Kit Lot Numbers: 1659079, 1696378; Recalled Supplier Component (in kit): A942216; Recalled Supplier Lot Number (in kit): NGKU3975, NGKU2887; 1. Model/Item Number (Kit): SHND419-08; UDI-DI: 10809160502389; Kit Lot Numbers: 1680504, 1695337; Recalled Supplier Component (in kit): A319514AM; Recalled Supplier Lot Number (in kit): NGKW2687, NGKV2393; 1. Model/Item Number (Kit): VAPX014-04; UDI-DI: 10809160332863; Kit Lot Numbers: 1701106, 1702175, 1702273; Recalled Supplier Component (in kit): A902416; Recalled Supplier Lot Number (in kit): NGKU4043; 1. Model/Item Number (Kit): WRNM035-20; UDI-DI: 10809160489277; Kit Lot Numbers: 1695943; Recalled Supplier Component (in kit): A319516AM; Recalled Supplier Lot Number (in kit): NGKT2391; 1. Model/Item Number (Kit): UFCF004-06; UDI-DI: 10809160487334; Kit Lot Numbers: 1666214, 1672814; 2. Model/Item Number (Kit): UFCF004-07; UDI-DI: 10809160513170; Kit Lot Numbers: 1695181; Recalled Supplier Component (in kit): A119216M; Recalled Supplier Lot Number (in kit): NGKT2404, NGKT3314; Model/Item Number (Kit): NAMC423-11; UDI-DI: 10809160490808; Kit Lot Numbers: 1671502; Recalled Supplier Component (in kit): A119216M; Recalled Supplier Lot Number (in kit): NGKT2404; Model/Item Number (Kit): NIHB0036-07; UDI-DI: 10809160403099; Kit Lot Numbers: 1657751; Recalled Supplier Component (in kit): A942216; Recalled Supplier Lot Number (in kit): NGKT3375; Model/Item Number (Kit): EURO053; UDI-DI: 10809160423813; Kit Lot Numbers: 1674613; Recalled Supplier Component (in kit): A902416…
The hazard
Product may be potentially contaminated with a lubricant used during the manufacturing process.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)