Class 2 Device Recall Laparotomy Sponge

• Date Initiated by Firm: March 01, 2019
• Create Date: March 28, 2019
• Recall Status: Terminated on April 06, 2021
• Recall Number: Z-1068-2019
• Recall Event ID: 82289
• Product Classification: Gauze/sponge, internal, x-ray detectable - Product Code GDY
• Product: Laparotomy Sponge with the following product description and model numbers: 1. Lap 18X18 XR (5 each/pack, 20 pack/case) - Model Number 300, 450, SM40018, V300; 2. Lap 18X18 XR (5 each/pack, 40 pack/case) - Model Number 400, 404, V400, V450; 3. Lap 18X18 XR w/ring (5 each/pack, 40 pack/case) - Model Number 402; 4. Lap 4X18 XR (5 each/pack, 40 pack/case) - Model Number 407; 5. Lap 12X12 XR (5 each/pack, 40 pack/case) - Model Number 411; 6. Lap 12X12 XR w/ring (5 each/pack, 40 pack/case) - Model Number 412; 7. Lap 8X36 XR (5 each/pack, 40 pack/case) - Model Number 419; 8. Lap 17X26 XR (5 each/pack, 20 pack/case) - Model Number 426
• Code Information: 1. Model Number (Lot Number, Expiration Date): 300 (000252968, 11/08/2022), 450 (1808JK318A, 08/30/2023), 450 (1807JK318A, 07/20/2023), SM40018 (1807JK323A, 07/20/2023), V300 (0000253083, 11/12/2022); 2. Model Number (Lot Number, Expiration Date): 400 (1808JK301B, 08/30/2023), 400 (1807JK301A, 07/20/2023), 404 (1808JK306A, 08/20/2023), V400 (1807JK319A, 07/20/2023), V450 (1808JK320A, 08/20/2023), V450 (1808JK320B, 08/30/2023); 3. Model Number (Lot Number, Expiration Date): 402 (1808JK304B, 08/30/2023), 402 (1808JK304A, 08/20/2023); 4. Model Number (Lot Number, Expiration Date): 407 (1808JK308A, 08/20/2023), 407 (1807JK308A, 07/20/2023); 5.Model Number (Lot Number, Expiration Date): 411 (1808JK311A, 08/20/2023), 411 (1808JK311B, 08/30/2023); 6. Model Number (Lot Number, Expiration Date): 412 (1808JK312B, 08/30/2023), 412 (1807JK312A, 07/20/2023), 412 (1808JK312A, 08/20/2023); 7. Model Number (Lot Number, Expiration Date): 419 (1807JK313A, 07/20/2023); 8. Model Number (Lot Number, Expiration Date): 426 (1808JK316B, 08/30/2023), 426 (1808JK316A, 08/20/2023)
• Recalling Firm/ Manufacturer: Medical Action Industries Inc; 25 Heywood Rd; Arden NC 28704-9302
• For Additional Information Contact: Nicole Early; 688281-338-7568
• Manufacturer Reason for Recall: Potential lack of sterility assurance
• FDA Determined Cause: Under Investigation by firm
• Action: Medical Action Industries notified customers on about 03/01/2019, via "URGENT: MEDICAL DEVICE NOTIFICATION OF RECALL." Instructions for end-users included to examine inventory for affected product, remove any affected product and immediately place it in quarantine, complete and return the provided Recall Response Form, and arrange for the return of all affected product on hand. Instructions for distributors included to examine inventory for affected product, remove any affected product and immediately place it in quarantine, notify any customers if affected product was further distributed, complete and return the provided Recall Response Form once all further distributed product is accounted for and those customers have responded, and arrange for the return of all affected product on hand. For replacement product, please contact MAI Customer Service at 1-800-645-7042.
• Quantity in Commerce: 228,300 packs (5 units/pack)
• Distribution: Distributed nationwide to AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, WY. Also distributed to Canada and Saudi Arabia.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.