FDA Medical Device Recalls (openFDA)
SIMPLIVIA HEALTHCARE LTD.: OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143
- Recall number
- Z-1057-2022
- Recalling firm
- SIMPLIVIA HEALTHCARE LTD.
- Product
- OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143
- Status
- Open, Classified
- Initiated
- 2022-03-08
- Posted
- not on file
- Terminated
- not on file
- Reason
- Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications.
- Root cause
- Equipment maintenance
- Action
- The recall notice and acknowledgement form dated 08 March 2022 were sent under B. Braun cover letter on 03/10/2022 via Certified USPS mail. Distributors are to forward the recall notification to customers to extend the recall to the end user/customer level. Identify current inventory, cease use and quarantine product subject to recall. Do not destroy, return product and complete the Product Removal Acknowledgement form. If you are a direct consignee of B. Braun Medical Inc. a B. Braun customer service representative will contact you to arrange for return of product. If you have received this recall notice from a customer of B. Braun, please return product to your local distributor to ensure proper credit and replacement of material. OnGuard Spike Port Adaptor may be used as an alternative to replace the OnGuard2 Bag Adaptor SP. If you have questions contact Simplivia: Shay Shaham, Sunday to Friday, 08:00 to 19:00 (GMT+2) at the following phone number: 97246908826.
- Quantity
- 293,520
- Distribution
- Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY.
- Lot, serial or model codes
- UDI: 37290115921435, Lots: UBE507, UBE508, UBE513, UBE516, UBE517, UBE509, UBE511, UBE512, UBE514, UBE515, UBE517, UBE518, UBE526, UBE530, UBE531, UBE534, UBE533, UBE535, UBE536
- 510(k) numbers
- ["K192866"]
- PMA numbers
- not on file
- Product code
- ONB
- Firm FEI
- 3002807615
- Firm city
- Kiryat Shmona
- Firm state
- not on file
- Firm country
- Israel
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28