Z-2251-2015Class II
Medical Device Exchange Chocolate Balloon Catheter/Over-the-Wire; Pouch, Tyvek/Mylar, Sterile, Single Use...
EXP Pharmaceutical Services Corp / initiated 2015-02-11 / Terminated / root cause: supplier
EXP Pharmaceutical Services Corp began a recall of Medical Device Exchange Chocolate Balloon Catheter/Over-the-Wire; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number CF14-150-25040-OTW. EXP... on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as supplier.
Recall record
- Recall number
- Z-2251-2015
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- EXP Pharmaceutical Services Corp
- Product
- Medical Device Exchange Chocolate Balloon Catheter/Over-the-Wire; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number CF14-150-25040-OTW. EXP (repackager), TriReme Medical (OEM) Catheter, angioplasty, peripheral, transluminal
- Product code
- LIT Catheter, Angioplasty, Peripheral, Transluminal
- 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.
- Root cause tag
- supplier
- FDA root cause
- Other
- Action
- EXP first notified their customers to quarantine EXP devices February 11-17, 2015. Customers were contacted through telephone, e-mail, and written communications. Customers were instructed to recover and quarantine all EXP products from their inventories. EXP believes that they have contacted all customers to whom products were shipped between April 26, 2014, and December 9, 2014. A second letter is scheduled to be sent in July 2015 (date unknown at this time). This letter will advise users of the recall of due to lack of registration with the FDA.
- Quantity in commerce
- 1
- Distribution
- Distributed in DC and the states of CO, CA, FL, TX, and AR.
- Product codes and lots
- OEM Catalog number CF14-150-25040-OTW.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2211-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2212-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2213-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2214-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2215-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2216-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2217-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2218-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2219-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2220-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2221-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2222-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2223-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2224-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2225-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2226-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2227-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2228-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2229-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2230-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2231-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2232-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2233-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2234-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2235-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2236-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2237-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2238-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2239-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2240-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2241-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2242-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2243-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2244-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2245-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2246-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2247-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2248-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2249-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2250-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2251-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2252-2015 | Class II | Terminated | Voluntary: Firm initiated |
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