FDA Medical Device Recalls (openFDA)
Vital Signs Devices, a GE Healthcare Company: Broselow/Hinkle Pediatric Emergency System Vital Signs Inc. 20 Campus Road Totowa, NJ 07512 USA The system supplies you with all the information and equipment needed for a young patients' emergency resuscitation requirements, all contained in a color coded, easy-to-use kit
- Recall number
- Z-0939-2012
- Recalling firm
- Vital Signs Devices, a GE Healthcare Company
- Product
- Broselow/Hinkle Pediatric Emergency System Vital Signs Inc. 20 Campus Road Totowa, NJ 07512 USA The system supplies you with all the information and equipment needed for a young patients' emergency resuscitation requirements, all contained in a color coded, easy-to-use kit
- Status
- Terminated
- Initiated
- 2011-10-17
- Posted
- 2012-02-02
- Terminated
- 2013-01-15
- Reason
- Povidone Iodine Pads included in the Vital Signs Broselow Pediatric Emergency Kit may be contaminated with Elizabethkinga meningoseptica.
- Root cause
- Material/Component Contamination
- Action
- GE Healthcare sent a recall letter/return response form dated October 17, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to not use the affected product, isolate and discard all affected product. Fill out the attached Confirmation form and fax back to 800-535-7923 per the instructions to obtain replacement Busse IV Start Kits. Also, consignees were instructed to return the attached response form even if no recalled product was in their inventory. If they forwarded any affected product to any other healthcare institutions, they should forward a copy of the letter to those institutions. For any questions regarding this recall call 1-800-932-0760.
- Quantity
- 6675 kits
- Distribution
- Nationwide and Foreign
- Lot, serial or model codes
- Class 1 Exempt Device No Medical Device Listing Number exp date - 13 months from the date received by the distributor. Povidone Iodine Pads: The Povidone Iodine Pad is packaged in the Busse IV Start Kit that is included in the Intra Venous Module, which is contained in the Broselow products referenced below. Affected Armstrong product numbers: Kits: AE-4700, AE 4701, AE-4712, and PBL-PC-9A Modules: 7700RIV, 7700PIV, 7700YIV, 7700WIV, 7700BIV, 7700OIV, 7700GIV, 7730RED, 7730PUR, 7730YEL, 7730WHI, 7730BLU, 7730ORG, and 7730GRN Affected Vital Signs product numbers: Kits: 7730ALS, 7730IALS, 7730FLY, 7730MOD Modules: 7700RIV2, 7700PIV2, 7700YIV2, 7700WIV2, 7700BIV2, 7700OIV2, 7700GIV2, 7730RED5, 7730PUR5, 7730YEL5, 7730WHI5, 7730BLU5, 7730ORG5, and 7730GRN5 Sub-Assembly: 7700RIV, 7700PIV, 7700YIV, 7700WIV, 7700BIV, 7700OIV, and 7700GIV Lot codes of the Broselow Kits and Intra Venous Modules that contain affected Povidone Iodine Pads: 2008: 228F-366F 2009: 010K-258K and 010L-258L
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OGL
- Firm FEI
- 2242551
- Firm city
- Totowa
- Firm state
- NJ
- Firm country
- not on file
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