CLASS II Device recall · Reported 11 May 2016 · FDA Enforcement Report
containing the strap labeled with "Adult" sticker recalled
Ferno-Washington is recalling containing the strap labeled with "Adult" sticker, distributed in 22 states. The recall was initiated on 10 Mar 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1604-2016
- FDA event ID
- 73641
- Recalling firm
- Ferno-Washington, Wilmington, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Mar 2016
- FDA classified
- 4 May 2016
- Reported
- 11 May 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 10 Mar 2016 | Recall initiated by company | |
| 4 May 2016 | Classified by FDA | +55 days |
| 11 May 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
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.
Where it was distributed
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..
AlaskaArizonaCaliforniaColoradoFloridaGeorgiaHawaiiIllinoisIndianaKentuckyMassachusettsMichiganMississippiNorth CarolinaNebraskaNew JerseyNew YorkOhioTexasVirginia
Questions about this recall
Why was it recalled?
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
Which lots are affected?
Strap Kit Adult Model 444
Where was it sold?
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..
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 73641This product is part of a recall event; the main page for the event is containing splint strap labeled with "Pediatric" sticker recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | containing splint strap labeled with "Pediatric" sticker recalled | Ferno-Washington | Labeling Errors | 22 states |
More recalls from Ferno-Washington
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Power F2 Powered Fastening System recalled by Ferno-Washington | Ferno-Washington | Other | Nationwide |
| Device | CLASS II | Ferno Power X2 Powered Ambulance Cot recalled by Ferno-Washington | Ferno-Washington | Other | Nationwide |
| Device | CLASS II | Ferno Power X1 Ambulance Cot recalled by Ferno-Washington | Ferno-Washington | Device Malfunction | Nationwide |
| Device | CLASS II | Ferno PROFlexx¿ recalled by Ferno-Washington | Ferno-Washington | Other | 6 states |
| Device | CLASS II | containing splint strap labeled with "Pediatric" sticker recalled | Ferno-Washington | Labeling Errors | 22 states |
Other Other Medical Devices recalls
All 13,908| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
| Device | CLASS II | Heart Prep Tray kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Sperm Ab Elisa (96 well plate test) recalled by DRG International | DRG International | Other | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |