Device, Gas Generating
Microbiology · 21 CFR 866.2580
Recent MDR events
23 adverse event reports on file
- BD GASPAK¿ EZ CAMPY CONTAINER SYSTEM SACHETSMay 4, 2026MalfunctionBecton Dickinson Caribe Ltd.2647876-2026-00048
- BD GASPAK¿ EZ CO2 GAS GENERATING POUCH SYSTEMApr 17, 2026MalfunctionBecton Dickinson Caribe Ltd.2647876-2026-00026
- BD GASPAK¿ EZ CO2 GAS GENERATING POUCH SYSTEMApr 15, 2026MalfunctionBecton Dickinson Caribe Ltd.2647876-2026-00023
- BD GASPAK¿ EZ CO2 GAS GENERATING POUCH SYSTEMApr 15, 2026MalfunctionBecton Dickinson Caribe Ltd.2647876-2026-00024
- BD BBL¿ DRY ANAEROBIC INDICATOR STRIPSApr 15, 2026MalfunctionBecton Dickinson Caribe Ltd.2647876-2026-00025
- BD GASPAK¿ EZ ANAEROBE GAS GENERATING POUCH SYSTEM WITH INDICATOROct 17, 2023MalfunctionBecton Dickinson & Co. (sparks)1119779-2023-01134
- BD GASPAK¿ EZ ANAEROBE GAS GENERATING POUCH SYSTEM WITH INDICATORSep 28, 2023MalfunctionBecton Dickinson Caribe Ltd.2647876-2023-00193
- BD GASPAK¿ EZ ANAEROBE CONTAINER SYSTEM WITH INDICATORAug 29, 2023MalfunctionBecton Dickinson Caribe Ltd.2647876-2023-00112
- BD GASPAK¿ EZ ANAEROBE CONTAINER SYSTEMMar 15, 2023MalfunctionBecton, Dickinson & Co. (sparks)1119779-2023-00289
- BD BBL¿ GASPAK¿ 100 ANAEROBIC SYSTEMMar 9, 2023MalfunctionBecton, Dickinson & Co. (sparks)1119779-2023-00262
Event type breakdown
Recalls
4 recall events for this product code
- Becton Dickinson & Co.Open, ClassifiedApr 29, 2026
BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use
BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.
Z-1982-2026 · View FDA record ↗ - Becton Dickinson & Co.Open, ClassifiedApr 29, 2026
BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use
BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.
Z-1983-2026 · View FDA record ↗ - Becton Dickinson & Co.TerminatedNov 26, 2010
GasPak EZ Large Incubation Container, a component of the GasPak EZ Gas Generating Container System, catalog # 260672, labeled in part ***Becton Dickinson and Co
In vitro diagnostic reagent containers may be defective and could cause incorrect test results in patient samples.
Z-0480-2011 · View FDA record ↗ - Becton Dickinson & Co.TerminatedJan 18, 2006
BBL GasPak Pouch System and BBL GasPak CampyPouch System, Catalog numbers 260651 and 260656, packed in boxes of 25
Microbiological based test system may be contaminated with bacteria and cause false clinical test results in patient samples.
Z-0406-06 · View FDA record ↗
Registered firms
19 firms currently registered for this product code
Scitek Global Co.,ltd
Jinan Shandong, CN
Mitsubishi Gas Chemical Co., Inc.
CHIYODA-KU Tokyo, JP
Hue Light Co., Ltd
Gwangmyeong-si Gyeonggi, KR
Becton, Dickinson & Co.
SPARKS, MD, US
Becton Dickinson Caribe Ltd.
CAYEY, PR, US
Infitek Co., Ltd.
Shanghai, CN
K&r Technologies Dba Microbiology International
Frederick, MD, US
Oxoid, Ltd.
BASINGSTOKE, HAMPSHIRE, GB
James Alexander Corp.
BLAIRSTOWN, NJ, US
Airgas Therapeutics Llc
PLUMSTEADVILLE, PA, US
Marken Healthtech Limited
NASHIK Maharashtra, IN
Nalge Nunc International Corporation
Rochester, NY, US
Advanced Instruments, Llc
NORWOOD, MA, US
P Bhogilal Pvt Ltd
Kolkata West Bengal, IN
Mark Enterprises
Nashik Maharashtra, IN
Rr Donnelley Global Turnkey Solutions
Juarez Chihuahua, MX
Thermo Fisher Scientific (monterrey)
Apodaca Nuevo Leon, MX
Labpeak Co.,ltd
Jinan Shandong, CN
510(k) clearances
18 clearances for this product code
- Fairleigh Dickinson Laboratories, Inc.Apr 27, 1988
K881502 · BREWER GEL FOR CAMPYLOBACTER
- Fairleigh Dickinson Laboratories, Inc.Jan 27, 1988
K875362 · BREWER GEL FOR ANAEROBES
- Bd Becton Dickinson Vacutainer Systems PreanalyticAug 6, 1987
K872782 · BBL(R) GASPAK CO2 POUCH(TM)
- Difco Laboratories, Inc.May 15, 1987
K871709 · ANAEROBIC TRANSPORT POUCH (CATALYST-FREE)
- Scott Laboratories, Inc.Apr 3, 1987
K871238 · ANABAG
- Marion Laboratories, Inc.Jun 16, 1986
K862123 · BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE
- Bd Becton Dickinson Vacutainer Systems PreanalyticAug 29, 1985
K853534 · BBL CAMPY POUCH
- Marion Laboratories, Inc.Mar 5, 1985
K845008 · BIO-BAG ENVIRONMENTAL CHAMBER -TYPE A-MULTI-PLATE