Bag, Reservoir
Anesthesiology · 21 CFR 868.5320
Recent MDR events
171 adverse event reports on file
- Portex Tubes BLUselect SuctionaidJul 29, 2026MalfunctionIcu Medical Nederland B.v.2025816-2026-00021
- PORTEX TUBES BLUSELECT SUCTIONAIDMay 12, 2026DeathIcu Medical Czech Republic A. S3012307300-2026-04863
- PORTEX TUBES BLUSELECT SUCTIONAIDMar 16, 2026MalfunctionIcu Medical, Inc.3012307300-2026-02467
- PORTEX TUBES BLUSELECT SUCTIONAIDMar 11, 2026MalfunctionIcu Medical Czech Republic A. S3012307300-2026-02310
- BREATHING BAGFeb 27, 2026MalfunctionIcu Medical Healthcare Manufacturing S.a. De C.v3012307300-2026-01814
- PORTEX TUBES BLUSELECT SUCTIONAIDFeb 18, 2026MalfunctionIcu Medical Healthcare Manufacturing S.a. De C.v.3012307300-2026-01426
- PORTEX TUBES BLUSELECT SUCTIONAIDJan 8, 2026MalfunctionIcu Medical Czech Republic A. S3012307300-2026-00232
- PORTEX TUBES BLUSELECT SUCTIONAIDDec 29, 2025MalfunctionIcu Medical Czech Republic A. S3012307300-2025-13765
- PORTEX TUBES BLUSELECT SUCTIONAIDDec 29, 2025MalfunctionIcu Medical Czech Republic A. S3012307300-2025-13764
- PORTEX TUBES BLUSELECT SUCTIONAIDDec 23, 2025MalfunctionIcu Medical Healthcare Manufacturing S.a. De C.v.3012307300-2025-13675
Event type breakdown
Recalls
7 recall events for this product code
- Draeger Medical, Inc.TerminatedMay 17, 2023
VentStar breathing bag Set (P) 110, MP00384
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Z-1445-2023 · View FDA record ↗ - Draeger Medical, Inc.TerminatedMay 17, 2023
VentStar Bag Set (N) 110, MP00383
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Z-1450-2023 · View FDA record ↗ - Teleflex Medical Europe LtdTerminatedApr 12, 2018
Latex Rebreathing Bags:
These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
Z-1367-2018 · View FDA record ↗ - Ventlab CorporationTerminatedSep 20, 2008
Ventlab-assembled Anesthesia breathing bags. The recall involves 3 Liter, 2 Liter and 1 Liter latex free bags used with Medline anesthesia circuit kits. The bag
During setup and potentially during procedures, the breathing bag can become separated from the taped bushing that is part of the breathing bag assembly.
Z-2324-2008 · View FDA record ↗ - Medline Industries IncTerminatedJun 25, 2008
1 Liter Latex-Free Breathing Bags; Reservoir Bag; Vendor Part Number: 720059B, Medline Item Number: 40056; Available in various Anesthesia Circuit Kits and Comp
Separation from Bushing: The breathing bag may separate from the bushing during use.
Z-1162-2008 · View FDA record ↗ - Medline Industries IncTerminatedJun 25, 2008
3 Liter Latex-Free Breathing Bag; Reservoir Bag; Vendor Part Number: 720057B, Medline Item Number: 40053; Available in various Anesthesia Circuit Kits and Compl
Separation from Bushing: The breathing bag may separate from the bushing during use.
Z-1163-2008 · View FDA record ↗ - Medline Industries IncTerminatedJun 25, 2008
2 Liter Latex-Free Breathing Bag; Reservoir Bag; Vendor Part Number: 720058B, Medline Item Number: 40054; Available in various Anesthesia Circuit Kits and Compl
Separation from Bushing: The breathing bag may separate from the bushing during use.
Z-1164-2008 · View FDA record ↗
Registered firms
100 firms currently registered for this product code
Productos Medline S.a. De C.v.
NUEVO LAREDO Tamaulipas, MX
Diptech Industries Sdn.bhd.
Sungai Petani Kedah, MY
Foremount Enterprise Co., Ltd.
Taichung City, TW
A-m Systems
Sequim, WA, US
Sunset Healthcare Solutions Central Warehouse
Elgin, IL, US
Boen Healthcare Co., Ltd.
Suzhou Jiangsu, CN
Vbm Medizintechnik Gmbh
SULZ AM NECKAR Baden-Wurttemberg, DE
Flexicare Medical (dongguan) Ltd.
DONGGUAN CITY Guangdong, CN
Medline Industries, Lp - Northfield
Northfield, IL, US
Narang Medical, Ltd.
New Delhi, IN
Deroyal Industries, Inc.
POWELL, TN, US
Heuer International (a Division Of Gst Corporation Limited)
NOIDA Uttar Pradesh, IN
Flight Medical Innovations Ltd.
PETACH TIKVA Central, IL
Pepper Medical, Inc.
West Chester, PA, US
Intersurgical Ltd.
WOKINGHAM, BERKSHIRE, GB
Bomimed Inc.
WINNIPEG, Manitoba, CA
Hebei Dingli Medical Apparatus And Instrument Co., Ltd
HENGSHUI CITY Hebei, CN
Pedia
Fairfax, VA, US
Convatec Limited, Gdc Building
Deeside Flintshire, GB
Draegerwerk Ag & Co. Kgaa
LUEBECK Schleswig-Holstein, DE
Create Biotech Co., Ltd.
Taoyuan City, TW
Jiangsu New Pentastar Medical Products Co. Ltd.
Changzhou Jiangsu, CN
Ups Supply Chain Solutions, Inc.
Louisville, KY, US
S & Mohr America, S.a. De C.v.
ESTADO DE MEXICO Ciudad de Mexico, MX
Tf New Material Sci And Tec Co.,ltd
Huainan Anhui, CN
510(k) clearances
19 clearances for this product code
- Pedia, LLCSep 25, 2018
K181424 · PeDIA
- Zefon Medical ProductsMay 27, 1994
K940220 · REBREATHER BAGS
- Precision Med Products, Ltd.Jul 16, 1993
K932496 · PRECISION MED PRODUCTS, LTD. BREATHING BAGS
- Med-Plastics Intl., Inc.Jul 16, 1993
K932581 · BREATHING BAGS
- Merit Medical Systems, Inc.Jul 16, 1993
K932584 · BREATHING BAGS
- Life Shield Healthcare Products, Inc.Jul 2, 1993
K932191 · BREATHING BAGS
- Med-Tek Corp.Sep 18, 1989
K894906 · ANESTHESIA BREATHING BAGS SIZES 1/2, 1,2,3 LITER
- King Systems Corp.Mar 3, 1988
K880680 · KING SYSTEMS, BREATHING BAG