Catheters, Suction, Tracheobronchial
Anesthesiology · 21 CFR 868.6810
Recent MDR events
3,457 adverse event reports on file
- BALLARDJul 17, 2026MalfunctionAvanos Medical Inc8030647-2026-00052
- AVANOSJul 16, 2026MalfunctionAvanos Medical Inc.8030647-2026-00051
- BALLARDJul 8, 2026MalfunctionAvanos Medical Inc.8030647-2026-00050
- BALLARD CLOSED SUCTION SYSTEMJul 1, 2026MalfunctionAvanos Medical Inc.8030647-2026-00047
- BALLARD CLOSED SUCTION SYSTEMJun 26, 2026MalfunctionAvanos Medical Inc.8030647-2026-00045
- BALLARD CLOSED SUCTION SYSTEMJun 26, 2026MalfunctionAvanos Medical Inc.8030647-2026-00046
- BALLARD CLOSED SUCTION SYSTEMJun 11, 2026MalfunctionAvanos Medical Inc.8030647-2026-00042
- DARJun 9, 2026MalfunctionCovidien9680661-2026-00038
- BALLARD CLOSED SUCTION SYSTEMJun 5, 2026MalfunctionAvanos Medical Inc8030647-2026-00036
- BALLARD CLOSED SUCTION SYSTEMJun 5, 2026MalfunctionAvanos Medical Inc8030647-2026-00037
Event type breakdown
Recalls
89 recall events for this product code
- Avanos Medical, Inc.Open, ClassifiedApr 16, 2025
Brand Name: Ballard
Lack of sterility assurance for closed suction catheter systems
Z-1521-2025 · View FDA record ↗ - Avanos Medical, Inc.Open, ClassifiedApr 16, 2025
Brand Name: Ballard
Lack of sterility assurance for closed suction catheter systems
Z-1522-2025 · View FDA record ↗ - Avanos Medical, Inc.Open, ClassifiedApr 16, 2025
Brand Name: Ballard
Lack of sterility assurance for closed suction catheter systems
Z-1523-2025 · View FDA record ↗ - Avanos Medical, Inc.Open, ClassifiedApr 16, 2025
Brand Name: Ballard
Lack of sterility assurance for closed suction catheter systems
Z-1524-2025 · View FDA record ↗ - Avanos Medical, Inc.Open, ClassifiedApr 16, 2025
Brand Name: Ballard
Lack of sterility assurance for closed suction catheter systems
Z-1525-2025 · View FDA record ↗ - Avanos Medical, Inc.Open, ClassifiedApr 16, 2025
Brand Name: Ballard
Lack of sterility assurance for closed suction catheter systems
Z-1526-2025 · View FDA record ↗ - Avanos Medical, Inc.Open, ClassifiedApr 16, 2025
Brand Name: Ballard
Lack of sterility assurance for closed suction catheter systems
Z-1527-2025 · View FDA record ↗ - Avanos Medical, Inc.Open, ClassifiedApr 16, 2025
Brand Name: Ballard
Lack of sterility assurance for closed suction catheter systems
Z-1528-2025 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedSep 6, 2024
Medline Convenience kits, labeled as:
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Z-2981-2024 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedFeb 25, 2024
MEDLINE BRONCHOSCOPY TRAY, REF DYNDL1350A
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
Z-1093-2024 · View FDA record ↗
Registered firms
259 firms currently registered for this product code
Convatec, Inc.
Greensboro, NC, US
Isomedix Operations Inc.
SAN DIEGO, CA, US
Ningbo Xinwell Medical Technology Co., Ltd.
Cixi Zhejiang, CN
Jwd. Technologies (jiangmen) Co.,ltd.
Jiangmen Guangdong, CN
Attract Kft.
Pecsvarad Baranya, HU
Dongguan Hong De Medical Plastic Products Co. Ltd.
Dongguan Guangdong, CN
Guangzhou Berrcom Medical Device Co., Ltd
Guangzhou Guangdong, CN
Avanos Medical, Inc.
Alpharetta, GA, US
Create Biotech Co., Ltd.
Taoyuan City, TW
Vygon Mfg
DOVER, NH, US
Harsoria Healthcare Pvt. Ltd. (unit-2)
Baddi Himachal Pradesh, IN
Cardinal Health 200, Llc
Waukegan, IL, US
Med Saver, Inc.
PHOENIXVILLE, PA, US
Chs Usa Incorporated
PEACHTREE CITY, GA, US
Philips Electronics Ltd
Mississauga Ontario, CA
Ningbo Mflab Medical Instruments Co., Ltd.
Ningbo Zhejiang, CN
Flexicare Medical (dongguan) Ltd.
DONGGUAN CITY Guangdong, CN
Lianyungang Aoke Medical Equipment Co.,ltd.
Lianyungang Jiangsu, CN
Medline Industries, Lp - Mexicali (mxc)
Mexicali Baja California, MX
Mcreat ( Guangzhou ) Bio-tech Co.,ltd
Guangzhou Guangdong, CN
Medsource Labs, Llc
Chanhassen, MN, US
Zhejiang Medtec Medical Devices Co., Ltd
Hangzhou Zhejiang, CN
Sterigenics Us Llc
Grand Prairie, TX, US
Jiangsu New Pentastar Medical Products Co. Ltd.
Changzhou Jiangsu, CN
Playhouse Method Inc. D/b/a Playhouse Md
Santa Monica, CA, US
510(k) clearances
116 clearances for this product code
- Mallinckrodt Dar S.R.L.Nov 25, 2003
K031997 · MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM
- Ambu, Inc.Oct 25, 1999
K992902 · AMBU HAND POWER SUCTION PUMP
- Spirit Medical Systems, Inc.Sep 22, 1998
K982945 · DUAL PURPOSE CLOSED CATHETER
- Ni-Med, Inc.Aug 24, 1998
K981910 · SUCTION CATHETER
- Mallinckrodt MedicalDec 29, 1997
K972258 · HI-CARE CLOSED SUCTION SYSTEM
- Amsino Intl., Inc.Sep 10, 1997
K973199 · AMSINO SUCTION CATHETER
- Sorenson Critical CareMar 11, 1997
K961707 · TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM
- Ballard Medical ProductsFeb 11, 1997
K964369 · TRACH CARE SET WITH MICROBAN