Z-1187-2024 Class I Ongoing
FDA device recall Z-1187-2024 was initiated by Avanos Medical, Inc. on Jan 16, 2024 and is designated Class I. Reason for recall: MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist. The recall status is ongoing. Affected quantity: 53126 Units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 13, 2024
- Initiation Date
- Jan 16, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 53126 Units
Product Description
MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: a) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16; b) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16-15; c) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16-22; d) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16-30; e) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 18 Fr, Product Code 0250-18; f) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 18 Fr, Product Code 0250-18-22; g) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 18 Fr, Product Code 0250-18-30; h) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 22 Fr, Product Code 0250-22; i) MIC* Gastric-Jejunal Feeding Tube Kit - Surgical Placement - 16 Fr, Product Code 0260-16; j) MIC* Gastric-Jejunal Feeding Tube Kit - Surgical Placement - 18 Fr, Product Code 0260-18; k) MIC* Gastric-Jejunal Feeding Tube Kit - Surgical Placement - 22 Fr, Product Code 0260-22;
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 0250-16, UDI/DI 00350770954806, Batch Numbers: 30180718, 30181870, 30184758, 30186768, 30194327, 30226669, 30226817, 30229831, 30240299, 30244886, 30248036, 30248348, 30251106, 30251988, 30254746, 30258134, 30267592; b) Product Code 0250-16-15, UDI/DI 00350770954813, Batch Numbers: 30185370, 30194326, 30249243, 30256710; c) Product Code 0250-16-22, UDI/DI 00350770954820, Batch Numbers: 30226808, 30238975; d) Product Code 0250-16-30, UDI/DI 00350770954837, Batch Numbers: 30184813, 30186749, 30190699, 30226816, 30235093, 30245070; e) Product Code 0250-18, UDI/DI 00350770954844, Batch Numbers: 30181844, 30181869, 30184757, 30185369, 30186748, 30189492, 30190698, 30195869, 30226668, 30226815, 30228967, 30229830, 30238122, 30238885, 30239857, 30238982, 30240298, 30240451, 30243197, 30242224, 30244885, 30250139, 30251984, 30254745, 20108481, 30256210, 30256482, 30257069, 30258133, 30259563, 30261698, 30262037, 30264281, 30267591, 30268254, 30270503, 30270858; f) Product Code 0250-18-22, UDI/DI 00350770954851, Batch Numbers: 30186747, 30188504, 30226814, 30238981, 30248034, 30253948, 30256709; g) Product Code 0250-18-30, UDI/DI 00350770954868, Batch Numbers: 30181868, 30184756, 30185379, 30186767, 30189491, 30190697, 30194325, 30195868, 30200971, 30226813, 30228966, 30229829, 30238121, 30240450, 30244884, 30248033, 30248345, 30254744, 30259562; h) Product Code 0250-22, UDI/DI 00350770954875, Batch Numbers: 30178410, 30181843, 30181867, 30184755, 30185368, 30195736, 30192113, 30195735, 30198033, 30226667, 30226812, 30228965, 30231399, 30238120, 30238512, 30238980, 30240484, 30240297, 30240449, 30250138, 30250166, 30252990, 30253947, 30254743, 30256209, 30256481, 80402126, 80402127, 30257064, 30259561, 30261697, 30262036, 30268253, 30270502, 30270857; i) Product Code 0260-16, UDI/DI 00350770954882, Batch Numbers: 30195867, 30245069, 30258131, 30267590; j) Product Code 0260-18, UDI/DI 00350770954899, Batch Numbers: 30181880, 30185383, 30195858, 30238884, 30239856, 30244880, 30250593, 30250160, 30262027, 30290826; k) Product Code 0260-22, UDI/DI 00350770954905, Batch Numbers: 30180717, 30186745, 30236828, 30238511, 30250165, 30259560, 30265343, 30290827
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1187-2024
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026