RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 The RBL2320, Low Profile Primary Guide is an ins

FDA device recall Z-0618-2024 · posted 2023-12-26 · Open, Classified

Recall details

Recalling firm

Acumed LLC

Reason for recall

Due to potential breakage during use.

Action taken

On 11/27/2023, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via FedEx and UPS ground to customers informing them that Acumed is initiating a Recall of all field inventory of Part Number RBL2320, Low Profile Primary Guides due to the potential for breakage during use. Customers are instructed to: IMMEDIATELY stop using and/or distributing the product and complete the following actions: 1-The RBL2320, Low Profile Primary Guide is often located with the RBL4030 Instrumentation Tray (as shown in Figure 2 above). Locate the RBL4030 tray and remove the RBL2320, Low Profile Primary guide(s) from the tray. Perform a physical count of their inventory of the RBL2320, Low Profile Primary Guides, and identify any inventory of the batch/lot numbers listed in the table above. 2-Remove the RBL2320, Low Profile Primary Guides removed/segregated in step 1, such that they are taken out of service (i.e., quarantined). 3-Record this data (product, batch/lot number, and quantity) on the Outstanding Field Action Survey found at the end of this recall letter (on page 5). If you do not have product to return, you are still required to complete the survey. 4) Return the completed survey via email to ellie.wood@acumed.net. 5) If you have RBL2320, Low Profile Primary Guide(s) to return, please contact Ellie Wood via email at ellie.wood@acumed.net so that a Return Authorization Number and return instructions can be provided. *Please note, only the RBL2320, Low Profile Primary Guide needs to be returned. 6) If RBL2320, Low Profile Primary Guide product is not returning, please post this Recall Notification Letter on or near the affected products.

Root cause

Unknown/Undetermined by firm

Status

Open, Classified

Product code

LXH

Quantity affected

513 units

Distribution

Worldwide - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, NJ, OH, OR, SC, TX, UT, VA, WA, and WI. The country of Australia

Date initiated

2023-11-27

Date posted

2023-12-26

Location

Hillsboro, OR