Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Equate (Walmart), Meijer, and Care Science (Amazon)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Equate (Walmart), Meijer, and Care Science (Amazon) see related information
Date Initiated by Firm March 02, 2022
Create Date May 04, 2022
Recall Status1 Open3, Classified
Recall Number Z-1031-2022
Recall Event ID 89824
Product Classification First Aid Kit with drug - Product Code LRR
Product First Aid Kits containing acetaminophen under brand names Equate (Walmart), Meijer, and Care Science (Amazon)
Code Information Product distributed in first kits under the following names/codes: 1) Equate (Walmart) - FIRST AID KIT 140 PIECES, SKU #s 566904301 and 567925067 - contains acetaminophen with Pouch lot #6132 (expired 09/2021). Kit was sold under ASO Item Nos: a) 187619: Lots 00106279 (EXP 4/1/2021); 00106525 (EXP 6/1/2020); 00106615 (EXP 3/1/2021); 00108538 (EXP 3/1/2021); 19252 (EXP.9/1/2021); and 19253 (EXP.9/1/2021) b) 188583: Lots 00106926 (EXP 6/1/2020); 00107119 (EXP 3/1/2021); 00108453 (EXP 3/1/2021); 00106615 (EXP 3/1/2021), and 00108538 (EXP 3/1/2021). 2) Meijer - FIRST AID KIT 150 PIECES, SKU #4212608-024-002 - contains acetaminophen with Pouch lot #6132 (expired 09/2021). Kit was sold under ASO Item No. 189099, Lot #00107831 (EXP 10/01/2020) 3) Care Science (Amazon) - FIRST AID KIT 200 PIECES, SKU #B07CQBNWQY - contains acetaminophen with Pouch lot #6132 (expired 09/2021). Kit was sold under ASO Item No. #188819, Lot #00112542 (EXP 06/01/2021).
Recalling Firm/
Manufacturer		 ASO LLC
300 Sarasota Center Blvd
Sarasota FL 34240-9381
For Additional Information Contact Frederico Juliao
941-941-379-0300 Ext. 1156
Manufacturer Reason
for Recall		 Kits contained recalled acetaminophen.
FDA Determined
Cause 2		 Material/Component Contamination
Action A customer letter dated 03/02/2022 was issued to consignees notifying them of the recall. Consignees are asked to contact the recalling firm to facilitate return of the product. A customer response form is included that must be completed and returned to the recalling firm. If the customers have any inventory of the expired products, they may send Collect via YRC Freight Service back to ASO, LLC in Sarasota, FL.
Quantity in Commerce 73,668 kits
Distribution US Nationwide distribution.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-