Drug recall
ACL PACK - 206039-Procedure Kit Catalog Number: UDAC66AA
FDA recall event 94765 · Class II · American Contract Systems Inc
Key facts
| Event ID | 94765 |
|---|---|
| Recall numbers | Z-2274-2024, Z-2275-2024, Z-2276-2024, Z-2277-2024, Z-2278-2024, Z-2279-2024, Z-2280-2024, Z-2281-2024, Z-2282-2024, Z-2283-2024, Z-2284-2024, Z-2285-2024 and 27 more |
| Recalling firm | American Contract Systems Inc |
| Product type | Devices |
| Products | ACL PACK - 206039-Procedure Kit Catalog Number: UDAC66AA, ACL, ST LUKES METHODIST 1CS Catalog Number: LMAC10AA, AHAR50K STANDARD ARTHROSCOPY PACK - 291852. Procedure tray Catalog Number: AHAR50K, ARTHO KNEE BAPTIST SOUTH PACK Procedure tray Catalog Number: BPKA49B, ARTHRO KNEE BEACHES PACK BHS- Procedure tray Catalog Number: BPKB46B and 34 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. |
| Initiation date | May 15, 2024 |
| Report date | Jul 17, 2024 |
| City | Tiffin |
| State | OH |
| Country | United States |
| FEI number | 3008492337 |
At a glance
- 10–99 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: