[Recalled] Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED TOTAL HIP PACK, REF 89-6664.03 surgical kits — Surgical kits and trays contain Stryker Hytrel Togas which were recalled becaus… | FDA 2012
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED TOTAL HIP PACK, REF 89-6664.03 surgical kits |
|---|---|
| Brand / manufacturer | DeRoyal Industries Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2008-2012 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 16 June 2012 |
| EAN / barcode | 22737521 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Surgical kits and trays contain Stryker Hytrel Togas which were recalled because the clear tape, that is intended to aid in the prevention of patient's fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from DeRoyal Industries Inc
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.
- 45W vs 100W USB-C Charger: Which Do I Need?
- Was ist (3E)-1,7,7-trimethyl-3-(4-methylbenzylidene)bicyclo[2.2.1]heptan-2-one (CAS 1782069-81-1)? Sicherheit, Regulierung & Perspektive EU/USA/Kanada | ProductGuru
- What is 1-(4-butoxy-1-naphthalenyl)tetrahydrothiophenium 1,1,2,2,3,3,4,4,4-nonafluoro-1-butanesulfonate? Safety, Regulation & EU/US/Canada Perspective | ProductGuru
- Cheese Reviews and Ratings: A Comprehensive Guide to the Best Cheeses Available
- What is 17-(4-nonylphenoxy)-3,6,9,12,15-pentaoxaheptadecan-1-ol (CAS 34166-38-6)? Safety, Regulation & EU/US/Canada Perspective | ProductGuru
- Was ist 2-Methoxyaniline, o-Anisidine (CAS 90-04-0)? Sicherheit, Regulierung & Perspektive EU/USA/Kanada | ProductGuru