Recalls / —
—#106398
Product
Irrigation Tray w/Bulb syringe, catalog# 900-020
- FDA product code
- KYZ — Syringe, Irrigating (Non Dental)
- Device class
- Class 1
- Medical specialty
- General Hospital
- 510(k) numbers
- K924809
- Affected lot / code info
- lot# 111010005, 111030737, 111030813, 111040954, 111051356, 111061630, 111071948, 111092564
Why it was recalled
The firm has determined that there is a possibility that packaging seals may be compromised. The issue could result in an injury to the patient due to product contamination or loss of sterility condition.
Root cause (FDA determination)
Packaging
Action the firm took
Customed Inc sent an Urgent Medical Device Recall letter dated December 8, 2011 to distributors via e-mail; then by certified (return and receipt) mail. The letter identified the product, description of problem, and actions to be taken. The letter included the following instructions: 1. Product should be removed from sale (Quarantine them) and cease distribution. Products affected shall NOT be used. 2. Return the enclosed acknowledgement form to Customed, Inc. Recall Coordinator whether or not the consignee has affected products. 3. If products has been futher distributed, sub-recall products - It is extremely important to notify your customers of this action by including a copy of this leller along with your formal notification. Please, instruct your customer to follow your directions for credit/replacemenl if they purchased the product from you. For qucstions. contact Cuslomed, Inc. Recall Coordinator at 787-622-5151 Ext. 7510.
Recalling firm
- Firm
- Customed, Inc Calle Igualdad Final # 7
- Address
- Fajardo, Puerto Rico 00738
Distribution
- Distribution pattern
- USA Nationwide Distribution - including Florida and Puerto Rico.
Timeline
- Recall initiated
- 2011-12-08
- Posted by FDA
- 2012-03-21
- Terminated
- 2017-04-12
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #106398. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.