TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,
FDA Recall Z-1033-2022 · Posted None
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Recalling FirmJohnson & Johnson Surgical Vision Inc
Recall StatusOpen, Classified
Product CodeHQC
Date Initiated2022-04-06
Reason for Recall
Potential breach in the sterility barrier for tray ring covers.
Firm Action
On April 11, 2022, Johnson & Johnson Surgical Vision, Inc. (JJSV) issued an "Urgent Medical Device Recall" Notification to all affected consignees via UPS. In addition to informing consignees about the recalled device, JJSV asked consignees to take the following actions:
1. Identify if any of your inventory contains Johnson & Johnson Surgical Vision Tray Ring Covers with Part Number OM271000.
2. Immediately discontinue using and remove from your inventory all affected Tray Ring Covers (P/N: OM271000). Note that no other JJSV Tray Ring Covers are affected by this recall.
3. EVEN IF YOU HAVE NO INVENTORY, please complete the attached Customer Reply Form (on page 4). JJSV requires this information for reconciliation purposes with regulatory agencies.
4. If you have inventory of the Tray Ring Cover with part number OM271000, please complete the Customer Reply Form, noting the Lot numbers of the Tray Ring Covers, and contact Customer Support at 1-877-266-4543 Option 2 to obtain a RGA number and arrange the product return.
Root Cause
Under Investigation by firm
Distribution Pattern
Worlwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, HI, IL, IN, KS, MA, MD, MN, MO, NC, NE, NJ, NM, NV, NY, OH, OR, PA, TN, TX, WA, WI and the countries of Chile, Indonesia, India, Japan, Malaysia, Philippines, Taiwan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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