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U.S. Department of Health and Human Services

Class 2 Device Recall SteriPack Sterile Polyester Spun Swabs

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  Class 2 Device Recall SteriPack Sterile Polyester Spun Swabs see related information
Date Initiated by Firm April 25, 2023
Date Posted June 15, 2023
Recall Status1 Open3, Classified
Recall Number Z-1970-2023
Recall Event ID 92334
Product Classification Applicator, absorbent tipped, sterile - Product Code KXG
Product SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area.
Catalog Number: 60566RevB
Code Information GTIN-DI: 00850027193205 Pack Lot Number : 85438; Individual Swab Lot Number: 86445 Exp Date: 28-Oct-2023
Recalling Firm/
Manufacturer		 LumiraDx
221 Crescent St
Waltham MA 02453-3475
Manufacturer Reason
for Recall		 Fails Post-Sterilization Sterile Swabs Cantilever (Bend) Testing and may be more susceptible to breakage. If the swab breaks in the nasal cavity of a patient may cause injury or medical intervention to remove part of the swab
FDA Determined
Cause 2		 Process control
Action LumiraDx issued on 25 April 2023 via email electronic Cover Letter and Urgent Product Recall Notice with an attestation form to document product destruction at their facility. Letter states reason for recall, health risk and action to take: Immediately stop using the affected lot of swabs " Remove from your stock any remaining affected kits of swabs. " Destroy all stock of affected swabs " Indicate the number of packs that were destroyed, and sign the attestation form at the end of this notice verifying destruction of the affected swabs in your inventory. " Report any issues or adverse events with using the affected swabs to LumiraDx immediately or to the FDA via the MedWatch program. " Please forward this notice to additional testing sites if these products were further distributed within your system. " LumiraDx will provide replacement product after receipt of the attestation form. Please contact CustomerServices.US@LumiraDx.com to arrange overnight shipment. Please complete and return the enclosed product destruction and attestation form to LumiraDx as soon as possible. If you have any questions, contact LumiraDx Technical Services at Technicalservices.US@lumiradx.com or 1-888-586-4721 option 1
Quantity in Commerce 1003 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.
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