Z-1186-2024 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 13, 2024
- Initiation Date
- January 16, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10808 units
Product Description
MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16; b) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-15; c) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-22; d) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-30; e) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 18 Fr, Product Code 8250-18; f) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 18 Fr, Product Code 8250-18-22; g) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 18 Fr, Product Code 8250-18-30; h) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 22 Fr, Product Code 8250-22; i) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Surgical Placement - 16 Fr, Product Code 8260-16; j) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Surgical Placement - 18 Fr, Product Code 8260-18; k) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Surgical Placement - 22 Fr, Product Code 8260-22
Reason for Recall
MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.
Distribution Pattern
Worldwide distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY including PR; and OUS (foreign) countries of: Canada, Colombia, Costa Rica, UAB, Israel, Kuwait, and Panama.
Code Information
a) Product Code 8250-16, UDI/DI 350770445410, Batch Numbers: 30180762, 30226671, 30226823, 30233440, 30238985, 30242039, 30254749, 30265005, 30266483, 30265374, 30268260, 30270862; b) Product Code 8250-16-15, UDI/DI 350770445427, Batch Numbers: 30226822, 30242228, 30253956; c) Product Code 8250-16-22, UDI/DI 00350770445434, Batch Numbers: 30184814, 30226821, 30247088, 30253955, 30262508, 30226820; d) Product Code 8250-16-30, UDI/DI 00350770445441, Batch Numbers: 30231400, 30238125 30247087, 30250300, 30258135, 30265373; e) Product Code 8250-18, UDI/DI 00350770445458, Batch Numbers: 30181846, 30184760, 30185381, 30226672, 30229833, 30233376, 30233439, 30235094, 30238124, 30238984, 30250140, 30251089, 30250169, 30254748, 30255675, 30256486, 80402128, 30259225, 30259566, 30261699, 30262040, 30264284, 30267593, 30268259, 30270505; f) Product Code 8250-18-22, UDI/DI 00350770445465, Batch Numbers: 30184824, 30228970, 30240302, 30247094, 30257066; g) Product Code 8250-18-30, UDI/DI 00350770445472, Batch Numbers: 30181900, 30226819, 30228969, 30240301, 30247092, 30252989, 30253953, 30259565, 30265004, 30265372, 30270861; h) Product Code 8250-22, UDI/DI 00350770445489, Batch Numbers: 30184759, 30185380, 30186750, 30221235, 30226670, 30226818, 30228968, 30238123, 30238475, 30238983, 30242226, 30242037, 30252072, 30252985, 30252998, 30255676, 30254747, 30256485, 30259224, 30262039, 30264283, 30267123, 30268258, 30270504, 30270860; i) Product Code 8260-16, UDI/DI 00350770445496, Batch Numbers: 30181845, 30223861, 30256484, 30290828; j) Product Code 8260-18, UDI/DI 00350770445502, Batch Numbers: 30185408, 30233438, 30242225, 30259226, 30264282, 30290830; k) Product Code 8260-22 UDI/DI 00350770445519, Batch Numbers: 30256483, 30259564, 30290829