FDA Device recall Z-1603-2016
Poly-bags containing splint strap labeled with "Pediatric" sticker
- FDA Device
- Class II
- terminated
- Published 2016-05-11
On 2016-05-11 the FDA classified a Class II recall of Poly-bags containing splint strap labeled with "Pediatric" sticker by Ferno Washington, citing on March 9, 2016, the firm was contacted regarding the possibility of incorrect labeling on the outside poly- bag of the traction splint straps. The firm investigated and determin….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1603-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-10 |
| Published | 2016-05-11 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ferno Washington |
| Distribution | AK, AZ, CA, CO, FL, GA, HI, IL, IN, KY, MA, MI, MS, NC, NE, NJ, NY, OH, TX, VA, WI, WV |
Product
Poly-bags containing splint strap labeled with "Pediatric" sticker. Each strap kit contains adjustable length leg straps, ankle wrap, a thigh pad and a heel stand. The strap kits are applied to the traction splint frame to immobilize and provide traction for a patients leg.
Reason
On March 9, 2016, the firm was contacted regarding the possibility of incorrect labeling on the outside poly- bag of the traction splint straps. The firm investigated and determined its supplier had labeled the outside packaging for the pediatric and adult traction splints straps incorrectly. The packaging labeled Adult contained a pediatric splint strap and the packaging labeled pediatric cont
Identifiers
| code_info | Strap Kit Pediatric Model 443 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1603-2016%22
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