Drug recall
Medical Device Exchange 10MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number…
FDA recall event 71608 · Class II · EXP Pharmaceutical Services Corp
Key facts
| Event ID | 71608 |
|---|---|
| Recall numbers | Z-2211-2015, Z-2212-2015, Z-2213-2015, Z-2214-2015, Z-2215-2015, Z-2216-2015, Z-2217-2015, Z-2218-2015, Z-2219-2015, Z-2220-2015, Z-2221-2015, Z-2222-2015 and 30 more |
| Recalling firm | EXP Pharmaceutical Services Corp |
| Product type | Devices |
| Products | Medical Device Exchange 10MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 9-AVP2-010; EXP (repackager), Aga Medical (OEM) Transcatheter septal occluder, Medical Device Exchange 10x40 Airway Stent System; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 90129-209; EXP (repackager), Aero (OEM) Prosthesis, tracheal, expandable, Medical Device Exchange 12MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 9-AVP2-012; EXP (repackager), Aga Medical (OEM) Transcatheter septal occluder, Medical Device Exchange 12x40 Airway Stent System; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 90129-212; EXP (repackager), Aero (OEM) Prosthesis, tracheal, expandable, Medical Device Exchange 2.15MMX22MM Fluted Spiral Router for CRANI-A; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number A-CRN-S; EXP (repackager), Anspach (OEM) Bur, surgical, general &… and 37 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had… |
| Initiation date | Feb 11, 2015 |
| Report date | Aug 5, 2015 |
| Termination date | Dec 30, 2015 |
| City | Fremont |
| State | CA |
| Country | United States |
| FEI number | 3004376386 |
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: