West Pharma Services Recalls Vial2BAG DC 20mm Medical Devices
West Pharma Services is recalling Vial2BAG DC 20mm devices because adverse events were reported with the similar 13mm model used with oxytocin in pregnant women.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Adverse events have been reported with the use of oxytocin in conjunction with the 13mm Vial2Bag DC in pregnant women. Vial2Bag DC 20mm is recalled due to similarities with 13mm Vial2Bag DC."
Plain-English summary
West Pharma Services IL, Ltd is recalling Vial2BAG DC 20mm devices (REF 6070112 & 6070112C). The recall is being conducted because adverse events have been reported with the use of oxytocin in conjunction with the 13mm Vial2Bag DC in pregnant women. The 20mm device is being recalled due to similarities with the 13mm model.
The affected products are single-use, prescription-only devices. The recall covers 30 million units distributed to a US distributor in Missouri. The source text does not specify the exact nature of the adverse events or the number of affected patients.
Consumers and healthcare providers should stop using the recalled devices and contact West Pharma Services for further instructions.
The recalled product
- Product
- Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only
- Manufacturer
- WEST PHARMA. SERVICES IL, LTD
- Affected units
- 30
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 7690
- 7750
- 7751
- 7865
- 7866
- 7867
- 7868
- 7886
- 7887
- 7888
- 7900
- 7901
- 7902
- 7957
- 7958
- 7959
- 7960
- 7949
- 7951
- 7952
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 3 recalled by WEST PHARMA. SERVICES IL, LTD under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · WEST PHARMA. SERVICES IL, LTD
See all →- SevereFDA Recalls Vial2BAG Transfer Device Due to Reported Adverse Events
FDA (Devices) · 2019-02-06
- SevereWest Pharma Vial2BAG DC 13mm Recalled for Adverse Events
FDA (Devices) · 2019-02-06
Same hazard · adverse event
See all →- SevereOlympus Thunderbeat Surgical Device Recall Over Adverse Events
FDA (Devices) · 2026-02-25
- SevereOlympus Thunderbeat Surgical Device Recall Due to Adverse Events
FDA (Devices) · 2026-02-25
- SevereCoolCurve+ Vacuum Applicator Recalled for Increased Paradoxical Hyperplasia Reports
FDA (Devices) · 2022-07-20
- HighSmith & Nephew Recalls Modular SMF Hip Prostheses Due to Adverse Events
FDA (Devices) · 2017-01-11
- HighSmith & Nephew Recalls Modular Hip Prosthesis Necks Due to Adverse Events
FDA (Devices) · 2017-01-11
Similar recalls
- ModerateWest Pharmaceutical Recalls Vial2Bag Advanced Devices Due to Sterile Barrier Risk
FDA (Devices) · 2024-11-06
- HighMedimop Recalls Vial2Bag DC Devices Due to IV Port Separation Risk
FDA (Devices) · 2018-03-21
- SeverePharmedium Recalls Subpotent Oxytocin Injection Bags Nationwide
FDA (Drugs) · 2017-11-01
- SevereWestern Drug Recalls HCG Vials Due to Sterility Concerns
FDA (Drugs) · 2015-12-09
- SevereWestern Drug Recalls M-Cobalamin Injections Due to Sterility Concerns
FDA (Drugs) · 2015-12-09
- SeverePharm D Solutions Recalls Oxytocin IV Bags Due to Sterility Concerns
FDA (Drugs) · 2018-11-07