Z-1603-2016Class II

Poly-bags containing splint strap labeled with "Pediatric" sticker. Each strap kit contains adjustable length...

Name: Z-1603-2016 Poly-bags containing splint strap labeled with "Pediatric" sticker. Each strap kit contains adjustable length...
Creator: Ferno-Washington Inc
Published: 2016-03-10
License: https://open.fda.gov/license/

Ferno-Washington Inc / initiated 2016-03-10 / Terminated / root cause: manufacturing process

FDA source

Ferno-Washington Inc began a recall of 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... on 2016-03-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1603-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-10
Posted: 2016-05-04
Terminated: 2016-08-23
Recalling firm: Ferno-Washington Inc
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.
Product code: NZD Stretcher, Patient Restraint
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 cont
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Ferno-Washington, Inc , has contacted all customers via telephone on March 10, 2016. All products will be replaced with new products. For further questions, please call: (937) 283-2885.
Quantity in commerce: 153
Distribution: Worldwide Distribution - US Distribution to the states of : AK ,AZ ,CA, CO, FL ,GA ,HI, IL ,IN ,KY ,MA ,MI ,MS ,NC ,NE ,NJ ,NY ,OH,ON,TX ,VA ,WI , and WV. There are no government accounts for this recall. There is one Canadian account for this recall. There are no Mexican accounts for this recall. and to the countries of : UAE, MALAYSIA, UNITED KINGDOM, SLOVAKIA, SOUTH AFRICA, QATAR and AUSTRALIA..
Product codes and lots: Strap Kit Pediatric Model 443

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1603-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1603-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-11	2016-05-04
Z-1604-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-11	2016-05-04

Product code NZD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)