Recalls / —
—#138841
Product
IRRIGATION TRAY W/BULB SYRINGE CUSTOMED 50/CS Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- FDA product code
- KYZ — Syringe, Irrigating (Non Dental)
- Device class
- Class 1
- Medical specialty
- General Hospital
- 510(k) numbers
- K924809
- Affected lot / code info
- Catalog number:900020 Lots: 150116955 exp. 1/31/16 150116713 exp. 1/31/16 150317568 exp. 2/28/16 150317568 exp. 2/28/16 150418231 exp. 4/30/16 150418231 exp. 4/30/16 150518598 exp. 5/31/16
Why it was recalled
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Root cause (FDA determination)
Packaging
Action the firm took
Customed issued an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" notification letter dated July 10, 2015 to all affected customers. The letter identified the product, problem, and actions to be taken by the customer.
Recalling firm
- Firm
- Customed, Inc Calle Igualdad Final # 7
- Address
- Fajardo, Puerto Rico 00738
Distribution
- Distribution pattern
- Distributed Only in Puerto Rico.
Timeline
- Recall initiated
- 2015-07-10
- Posted by FDA
- 2015-09-03
- Terminated
- 2017-04-12
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #138841. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.