Recall Z-2215-2015
EXP Pharmaceutical Services Corp · initiated February 11, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medical Device Exchange - Trocar VersaPort Plus V2; 5mm -11mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 179095P; EXP (repackager), Auto Suture (OEM) Laparoscope, General and Plastic Surgery
Codes / lots: OEM Catalog number 179095P.
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.
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-2215-2015
- Initiated
- February 11, 2015
- Posted by FDA
- July 24, 2015
- Terminated
- December 30, 2015
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Quantity
- 4
- Distribution
- Distributed in DC and the states of CO, CA, FL, TX, and AR.
- Recalling firm
- EXP Pharmaceutical Services Corp, Fremont, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2211-2015 Class II | Medical Device Exchange Surgical Gown - Flyte Hood Pouch, Tyvek/Mylar, Sterile, Single…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | 02/11/2015Terminated |
| Z-2212-2015 Class II | Medical Device Exchange - GelPort Laparoscopic System; Pouch, Tyvek/Mylar, Sterile…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | 02/11/2015Terminated |
| Z-2213-2015 Class II | Medical Device Exchange - KII FIOS FIRST ENTRY 5X100MM; Pouch, Tyvek/Mylar, Sterile…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | 02/11/2015Terminated |
| Z-2214-2015 Class II | Medical Device Exchange - 5.5mm BioComposite Corkscrew FT, Vented Suture Anchor; Pouch…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | 02/11/2015Terminated |
| Z-2216-2015 Class II | Medical Device Exchange - Endo Catch 10mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | 02/11/2015Terminated |
| Z-2217-2015 Class II | Medical Device Exchange - GIA Auto Suture Loading Unit w/ DST Series Technology 80mm -…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | 02/11/2015Terminated |
| Z-2218-2015 Class II | Medical Device Exchange - Versaport Bladeless Trocar w/ Fixation Cannula 5mm; Pouch…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | 02/11/2015Terminated |
| Z-2219-2015 Class II | Medical Device Exchange - Loading Unit w/ DST Series Technology 60mm - 3.5mm; Pouch…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | 02/11/2015Terminated |
| Z-2220-2015 Class II | Medical Device Exchange - Dilating Tip Trocar w/Stability Sleeve 11mm; Pouch…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | 02/11/2015Terminated |
| Z-2221-2015 Class II | Medical Device Exchange - Dilating Tip Trocar w/Stability Sleeve 12mm; Pouch…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | 02/11/2015Terminated |
| Z-2222-2015 Class II | Medical Device Exchange - Mayfield Disposable Skull Pin; Pouch, Tyvek/Mylar, Sterile…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | 02/11/2015Terminated |
| Z-2223-2015 Class II | Medical Device Exchange - Silicone Round Drain; Pouch, Tyvek/Mylar, Sterile, Single Use…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | 02/11/2015Terminated |
| Z-2224-2015 Class II | Medical Device Exchange - Auto Suture Endo Universal 65 4mm; Pouch, Tyvek/Mylar…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | 02/11/2015Terminated |
| Z-2225-2015 Class II | Medical Device Exchange -Suction Coagulator; Pouch, Tyvek/Mylar, Sterile, Single Use…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | 02/11/2015Terminated |
| Z-2226-2015 Class II | Medical Device Exchange -APPLIER, MULTICLIP ROTATING; Pouch, Tyvek/Mylar, Sterile…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | 02/11/2015Terminated |
| Z-2227-2015 Class II | Medical Device Exchange -SYSTEM, TACKER SKIN 5MM; Pouch, Tyvek/Mylar, Sterile, Single…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | 02/11/2015Terminated |
| Z-2228-2015 Class II | Medical Device Exchange BAG, SPECIMEN RETRIEVER ENDO; Pouch, Tyvek/Mylar, Sterile…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | 02/11/2015Terminated |
| Z-2229-2015 Class II | Medical Device Exchange ETS FLEX 45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45MM STAPLE…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | 02/11/2015Terminated |
| Z-2230-2015 Class II | Medical Device Exchange FIBERWIRE SUTURE SCISSOR; Pouch, Tyvek/Mylar, Sterile, Single…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | 02/11/2015Terminated |
| Z-2231-2015 Class II | Medical Device Exchange FEMORAL CANAL TIP; Pouch, Tyvek/Mylar, Sterile, Single Use Only…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | 02/11/2015Terminated |
| Z-2232-2015 Class II | Medical Device Exchange Insufflation Needle; Pouch, Tyvek/Mylar, Sterile, Single Use…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | 02/11/2015Terminated |
| Z-2233-2015 Class II | Medical Device Exchange 10MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | 02/11/2015Terminated |
| Z-2234-2015 Class II | Medical Device Exchange 12MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | 02/11/2015Terminated |
| Z-2235-2015 Class II | Medical Device Exchange PT WIRE 300; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | 02/11/2015Terminated |
| Z-2236-2015 Class II | Medical Device Exchange X-SAW BLADE; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | 02/11/2015Terminated |
| Z-2237-2015 Class II | Medical Device Exchange Wire (sternotomy wire); Pouch, Tyvek/Mylar, Sterile, Single Use…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | 02/11/2015Terminated |
| Z-2238-2015 Class II | Medical Device Exchange Round Fluted Bur Soft Touch; 2.0mm; Pouch, Tyvek/Mylar, Sterile…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | 02/11/2015Terminated |
| Z-2239-2015 Class II | Medical Device Exchange Round Diamond Bur Extra Coarse; 3.0mm; Pouch, Tyvek/Mylar…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | 02/11/2015Terminated |
| Z-2240-2015 Class II | Medical Device Exchange 6.0mm Round Fluted Bur Soft Touch; Pouch, Tyvek/Mylar, Sterile…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | 02/11/2015Terminated |
| Z-2241-2015 Class II | Medical Device Exchange Round Fluted Bur Aggressive; 4.0mm; Pouch, Tyvek/Mylar, Sterile…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | 02/11/2015Terminated |