EXP Pharmaceutical Services Corp Recall: Medical Device Exchange PT WIRE 300; Pouch, Tyvek
EXP Pharmaceutical Services Corp Recall: Medical Device Exchange PT WIRE 300; Pouch, Tyvek is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: EXP Pharmaceutical Services Corp; Product: Medical Device Exchange PT WIRE 300; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 38
| Recalling firm | EXP Pharmaceutical Services Corp |
|---|---|
| Product | Medical Device Exchange PT WIRE 300; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 38931-04; EXP (repackager), Boston Scientific (OEM) Wire, guide, catheter |
| 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 their own quality systems. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Distributed in DC and the states of CO, CA, FL, TX, and AR. |
| Recall initiated | 20150211 |
| Recall number | Z-2235-2015 |
| Category | device |
| State | CA |
| Country | United States |
$29/mo
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