Recall Z-2212-2015— EXP Pharmaceutical Services Corp
Class II · Terminated
Class II FDA medical device recall by EXP Pharmaceutical Services Corp, initiated 2015-02-11, terminated 2015-12-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Medical Device Exchange - GelPort Laparoscopic System; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number C8XX2N0NCE. EXP (repackager), Applied Medical (OEM) Laparoscope, General & Plastic Surgery.. Reason: 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..
- Recalling firm
- EXP Pharmaceutical Services Corp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-02-11
- Terminated
- 2015-12-30
- Firm location
- Fremont, CA, United States
Product description
Medical Device Exchange - GelPort Laparoscopic System; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number C8XX2N0NCE. EXP (repackager), Applied Medical (OEM) Laparoscope, General & Plastic Surgery.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.