Poly-bags containing the strap labeled with "Adult" sticker — Class II medical device recall Z-1604-2016
Terminated recall by Ferno-Washington Inc, reported 2016-05-11, distributed in AK, AZ, CA, CO, FL, GA, HI, IL…. On March 9, 2016, the firm was contacted regarding the possibility of incorrect labeling on the outside poly-
| Recall number | Z-1604-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ferno-Washington Inc, Wilmington, OH, United States |
| Recall initiated | 2016-03-10 |
| Classified | 2016-05-04 |
| Reported by FDA | 2016-05-11 |
| Terminated | 2016-08-23 |
| Distributed | AK, AZ, CA, CO, FL, GA, HI, IL, IN, KY, MA, MI, MS, NC, NE, NJ, NY, OH, TX, VA, WI, WV |
| Countries outside the US | AE, AU, GB, MY, QA, SK, ZA |
| Quantity | 270 |
| Reason classes | labeling |
| Model numbers | 444 |
Product
Poly-bags containing the strap labeled with "Adult" 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 for recall
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 conta
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1604-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.