Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2) 89-10508.02,

FDA device recall Z-1691-2023 · posted 2023-06-07 · Open, Classified

Recall details

Recalling firm

DeRoyal Industries Inc

Reason for recall

The custom procedure packs contain light handle covers that have been recalled by another firm.

Action taken

The recalling firm issued a letter dated 4/14/2023 to their sole consignee via email on 4/17/2023. The letter explained the reason for recall, the risk associated with the use of the device, and referred the customer to see the attached Affected Products Listing for detailed information, as the spreadsheet indicates the DeRoyal product numbers and lot numbers shipped to the customer. Additionally, the spreadsheet indicates the STERIS reference number, LB53, and lot numbers affected. The letter points out the recall is for the sterile STERIS light handle cover and the rest of the pack is not affected or impacted by the recall. The customer is to take the following actions: (1) Using the attached Affected Products Listing, identify the affected surgical pack numbers in your inventory and place it in quarantine to prevent further use. Place the label provided on each case and individual pack indicating that upon use, to remove and discard/destroy the STERIS Light Handle Covers that are contained within the pack; (2) Complete the Notice of Destruction Form indicating the number of affected products labeled and the customer will be given credit for the product discarded/destroyed. The completed form was to be returned to the recalling firm via FAX or email no later than 5/12/2023. (3) The customer is to complete and return the notice of destruction form even if they no longer have any product. (4) If the product has been further distributed, they are to notify their customers of the recall, which can be done by forwarding the recall notification onto the downstream customer or having the recalling firm notify their downstream customers. The recalling firm later discovered there were additional products to be included in the recall and notified their sole consignee via email on 5/16/2023 containing an updated spreadsheet of products.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

LRO

Quantity affected

1,391 cases (2,972 packs)

Distribution

US Nationwide distribution in the state of VA.

Date initiated

2023-04-17

Date posted

2023-06-07

Location

Powell, TN

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