Laparotomy Sponge with the following product description and model numbers: 1. Lap 18X18 XR...
FDA Device Recall #Z-1068-2019 — Class II — March 1, 2019
Recall Summary
| Recall Number | Z-1068-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 1, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medical Action Industries Inc |
| Location | Arden, NC |
| Product Type | Devices |
| Quantity | 228,300 packs (5 units/pack) |
Product Description
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;
Reason for Recall
Potential lack of sterility assurance
Distribution Pattern
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.
Lot / 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);
Other Recalls from Medical Action Industries Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0681-2019 | Class II | Laparotomy Sponge, XR No Loop, Single-Use, Ster... | Nov 27, 2018 |
| Z-2043-2018 | Class II | Medical Action Industries Inc. Blue OR Towel No... | Dec 11, 2017 |
| Z-2101-2017 | Class II | White OR Towels, X-Ray Detectable, Sterile, 4 T... | Apr 19, 2017 |
| Z-2102-2017 | Class II | Blue OR Towels, X-Ray Detectable, Sterile, 2 To... | Apr 19, 2017 |
| Z-1036-2016 | Class II | PICC/CVC Secure Dressing Change kit, Ref: 73775... | Feb 3, 2016 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.