Avanos Medical, Inc.: AVANOS MIC-KEY SF Gastrostomy Feeding Tube

Recall number

Z-2969-2020

Recalling firm

Avanos Medical, Inc.

Product

AVANOS MIC-KEY SF Gastrostomy Feeding Tube

Status

Terminated

Initiated

2020-07-29

Posted

not on file

Terminated

2023-01-31

Reason

Devices had cracked or detached from the feeding tube body

Root cause

Under Investigation by firm

Action

Avanos issued urgent product safety advisory notice on august 12, 2020. It states the following: 1. CHECK all storage and usage locations to determine if any impacted product remains 2. DISCONTINUE using the impacted product 3. If you have UNUSED INVENTORY: " SEGREGATE and QUARANTINE the devices according to your facilitys procedures " IMMEDIATELY COMPLETE and RETURN the Acknowledgement Form and return to Avanos. Please email form to avanos7528@stericycle.com or FAX to 877- 857-4143 . Please note that Avanos is contracting with Stericycle to help manage this Advisory Notice communication. Please contact Avanos directly at 678-488-8563 to obtain replacement feeding tube(s) or to be issued a credit. 4. If the INVENTORY ALREADY USED OR IN-USE " IMMEDIATELY COMPLETE the Acknowledgement Form. If no impacted devices remain in your facilitys inventory, please check the box indicating that you have no inventory remaining. " For your patients who have been provided impacted devices and are currently using a MIC-KEY SF Gastrostomy Feeding please contact each patient and advise them to follow one of the following scenarios 1. Patient is currently using an impacted device? a. Not all feeding port hubs will detach from the feeding tube, but it may happen at any time after placement (e.g., soon after placement of the feeding tube or months after use): b. If the patient has a mature stoma, please advise patient to replace the impacted MIC-KEY SF Gastrostomy Feeding Tube with a different model feeding tube having a comparable size. c. If the patient has an immature stoma, consider replacing the feeding tube now, or taping over the hub as described below. d. If you and your patient decide not to replace the device, please advise patient to check on the tube and feeding port hub frequently throughout the day for cracks or potential leaks or detachment (a leak around the feeding port hub could mean that detachment may occur). If leakage around the feedi

Quantity

284 units

Distribution

US states: OK IL WI PA TX IL PA NJ OK LA OUS: Belgium

Lot, serial or model codes

REF Product Code: 7120-12-1.0; Size 12Fr, 1.0 cm; Lot # 30041194  REF Product Code: 7120-12-1.7; Size: 12Fr, 1.7 cm; Lot # 30039482  REF Product Code: 7120-12-4.5; Size: 12Fr, 4.5cm; Lot # 30057268  REF Product Code: 7120-14-0.8; Size:14Fr, 0.8cm; Lot # 30020939  REF Product Code: 7120-14-1.0; Size: 14Fr, 1.0cm; Lot # 30012320, 30020940  REF Product Code: 7120-14-1.2; Size: 14Fr, 1.2cm; Lot # 30020941, 30046143  REF Product Code: 7120-14-1.5; Size: 14Fr, 1.5cm; Lot # 30012322, 30027259  REF Product Code: 7120-14-1.7; Size: 14Fr, 1.7cm; Lot # 30012323  REF Product Code: 7120-14-2.0; Size:14Fr, 2.0cm; Lot # 30012326, 30018098  REF Product Code: 7120-14-2.3; Size: 14Fr, 2.3cm; Lot # 30018099  REF Product Code: 7120-14-2.5; Size: 14Fr, 2.5cm; Lot # 30012328  REF Product Code: 7120-14-2.7; Size: 14Fr, 2.7cm; Lot # 30012324  REF Product Code: 7120-14-3.0; Size: 14Fr, 3.0cm; Lot # 30012327  REF Product Code: 7120-14-3.5; Size: 14Fr, 3.5cm; Lot # 30041187  REF Product Code: 7120-16-5.5; Size: 16Fr, 5.5cm; Lot # 30046156  REF Product Code: 7140-12-1.5; Size: 12Fr, 1.5cm; Lot # 30015733  REF Product Code: 7140-14-0.8; Size: 14Fr, 0.8cm; Lot # 30020938  REF Product Code: 7140-14-1.0; Size: 14Fr, 1.0cm; Lot # 30072145, 30020061  REF Product Code: 7140-14-1.2; Size: 14Fr, 1.2cm; Lot # 30020062  REF Product Code: 7140-14-1.5; Size: 14Fr, 1.5cm; Lot # 30020063  REF Product Code: 7140-14-1.7; Size: 14Fr, 1.7cm; Lot # 30020064, 30049920  REF Product Code: 7140-14-2.0; Size: 14Fr, 2.0cm; Lot # 30020065  REF Product Code: 7140-14-2.3; Size: 14Fr, 2.0cm; Lot # 30020066  REF Product Code: 7140-14-2.5; Size: 14Fr, 2.5cm; Lot # 30020067  REF Product Code: 7140-14-3.5; Size: 14Fr, 3.5cm; Lot # 30021846  REF Product Code: 7140-14-4.0; Size: 14Fr, 4.0cm; Lot # 30021847  REF Product Code: 7140-14-4.5; Size: 14Fr, 4.5cm; Lot # 30021848  REF Product Code: 7140-14-5.0; Size: 14Fr, 5.0cm; Lot # 30044458  REF Product Code: 7140-16-1.0; Size: 16Fr, 1.0cm; Lot # 30058995  REF Product Code: 7140-16-1.5; Size: 16Fr, 1.5cm; Lot # 30021429  REF Product Code: 7140-16-2.3; Size: 16Fr, 2.3cm; Lot # 30021432, 30057743  REF Product Code: 7140-16-2.5; Size: 16Fr, 2.5cm; Lot # 30052745  REF Product Code: 7140-18-2.3; Size: 18Fr, 2.3cm; Lot # 0002968773  REF Product Code: 7140-18-5.5; Size: 18Fr, 5.5cm; Lot # 30052898  REF Product Code: 7140-20-2.0; Size: 20Fr, 2.0cm; Lot # 30054211

510(k) numbers

["K122653"]

PMA numbers

not on file

Product code

KNT

Firm FEI

3011270181

Firm city

Alpharetta

Firm state

GA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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