Class I Recall

MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: a) MIC* Gastric-Jejunal Feeding Tube Kit -

Summary

The FDA issued a Class I for MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: a) by Avanos Medical, Inc.. Reason: MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist..

Details

Source

Device Recall

External ID

Z-1187-2024

Action Date

2024-03-13

Status

Ongoing

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;

Lot/Code Info: 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

Quantity Affected: 53126 Units

Reason for Recall

MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.

Distribution

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2024-01-16

Company

Avanos Medical, Inc.

Alpharetta, GA

Context & Analysis

This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.

This was one of 225 device recalls issued in the same week, part of 403 device-related FDA actions this month.

Avanos Medical, Inc. has 55 FDA actions in our database, including 51 recalls and 4 clearances.

Frequently Asked Questions

What is a Class I recall?

A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Avanos Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Avanos Medical, Inc. have FDA actions?

Avanos Medical, Inc. has 55 FDA actions in our database, including 51 recalls and 4 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-1187-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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