DeviceSignal · Recall classified
BD SWITZERLAND SARL
FDA classified a device recall on 2026-08-13 · Class II · Z-2941-2026
EventRecall classified
Effective2026-08-13
ClassificationClass II
On 2026-08-13 the FDA classified a device recall from BD SWITZERLAND SARL as Class II. Product: 60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus…. Recall Z-2941-2026. The firm initiated it on 2026-06-16. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2941-2026
- Classification
- Class II
- Classified on
- 2026-08-13
- Initiated on
- 2026-06-16
- Firm
- BD SWITZERLAND SARL
- Reason
- Products may not have received adequate sterilization processing.
- Product
- 60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C UDI-DI code: 10885403274619 9 IN Extension Set w/Max Y REF MPX5300-C UDI-DI code: 10885403237218 Intravascular Administration Set and Extension Set used to administer fluids.
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-2941-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
12ede5fadea39b9620f8db81e36fc882107456bdfd0d2157d2883dd03d6ed80e- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)