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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Topical Products

Prevantics Swabs and Swabsticks Recalled for Manufacturing Quality Issues

Agency Publication Date: February 18, 2022
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Summary

Professional Disposables International, Inc. has recalled approximately 198,250 cases of Prevantics antiseptic swabs and swabsticks, which contain chlorhexidine gluconate (3.15% w/v) and isopropyl alcohol (70% v/v). The recall was initiated due to manufacturing quality issues and concerns regarding the testing methods used during production. These products are commonly used for skin preparation before medical procedures. No injuries or adverse events have been reported to date.

Risk

Manufacturing quality deviations can lead to products that do not meet safety or effectiveness standards. If these antiseptic products are sub-potent or lack proper quality validation, they may not effectively sanitize the skin, potentially increasing the risk of infection during medical procedures.

What You Should Do

  1. This recall affects Prevantics brand Maxi Swabsticks, Swabs, and Swabsticks containing chlorhexidine gluconate and isopropyl alcohol, used for pre-operative or pre-injection skin preparation.
  2. Identify your product by checking the packaging for NDC numbers 10819-4076-4, 10819-4076-3, 10819-1080-1, 10819-1080-2, 10819-4077-1, 10819-4077-4, 10819-4077-2, or 10819-4077-3. See the Affected Products section below for the full list of affected codes.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Contact Professional Disposables International, Inc. directly for further instructions regarding this recall.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Prevantics Maxi Swabstick (0.172 fl. Oz. / 5.1 mL)
Variants: 3.15% w/v chlorhexidine gluconate, 70% v/v isopropyl alcohol, 30 Individual Maxi Swabsticks per carton, 300 Individual Swabsticks per case
Model:
S41950
S27350
Lot Numbers:
12000315 (Exp Feb 2022)
12000700 (Exp Mar 2022)
12001112 LE (Exp Jun 2022)
12001214 (Exp Jul 2022)
12001362 (Exp Aug 2022)
12001406 (Exp Aug 2022)
12001628 (Exp Sep 2022)
12001856 (Exp Oct 2022)
12002103 (Exp Dec 2022)
12002113 (Exp Jan 2023)
12100024 (Exp Jan 2023)
12100226 (Exp Feb 2023)
12100227 (Exp Feb 2023)
12100443 (Exp Mar 2023)
12100503 (Exp Mar 2023)
12100516 (Exp Apr 2023)
12100517 (Exp Apr 2023)
12100748 (Exp May 2023)
12100756 (Exp May 2023)
12001113 LE (Exp Jun 2022)
12001289 (Exp Jul 2022)
12001240 (Exp Jul 2022)
12002104 (Exp Dec 2022)
12100025 (Exp Jan 2023)
12100405 (Exp Mar 2023)
12100674 (Exp Apr 2023)
12100779 (Exp May 2023)
NDC:
10819-4076-4
10819-4076-3

Packaged as individual pouches in cartons or cases.

Product: Prevantics Swab (0.034 fl. Oz. / 1 mL)
Variants: 3.15% w/v chlorhexidine gluconate, 70% v/v isopropyl alcohol, 100 Individual Swabs per carton, 3000 Individual Swabs per case
Model:
B10800
B11400
Lot Numbers (150):
12000165 (Exp Feb 2022)
12000166 (Exp Feb 2022)
12000382 (Exp Feb 2022)
12000228 (Exp Mar 2022)
12000381 (Exp Mar 2022)
12000383 (Exp Mar 2022)
12000577 (Exp Mar 2022)
12000578 (Exp Mar 2022)
12000579 (Exp Mar 2022)
12000661 (Exp Mar 2022)
12000662 (Exp Mar 2022)
12000659 (Exp Apr 2022)
12000660 (Exp Apr 2022)
12001060 (Exp Jun 2022)
12001061 (Exp Jun 2022)
12001062 (Exp Jun 2022)
12001100 LE (Exp Jun 2022)
12001101 LE (Exp Jun 2022)
12001233 (Exp Jul 2022)
12001234 (Exp Jul 2022)
12001235 (Exp Jul 2022)
12001236 (Exp Jul 2022)
12001351 (Exp Aug 2022)
12001394 (Exp Aug 2022)
12001395 (Exp Aug 2022)
12001396 (Exp Aug 2022)
12001397 (Exp Aug 2022)
12001398 (Exp Aug 2022)
12001399 (Exp Aug 2022)
12001632 (Exp Sep 2022)
12001633 (Exp Sep 2022)
12001634 (Exp Sep 2022)
12001635 (Exp Sep 2022)
12001636 (Exp Sep 2022)
12001637 (Exp Oct 2022)
12001638 (Exp Oct 2022)
12001639 (Exp Oct 2022)
12001640 (Exp Oct 2022)
12001641 (Exp Oct 2022)
12001721 (Exp Oct 2022)
12001791 (Exp Oct 2022)
12001792 (Exp Nov 2022)
12001793 (Exp Nov 2022)
12001794 (Exp Nov 2022)
12001962 (Exp Nov 2022)
12002039 (Exp Jan 2023)
12002040 (Exp Jan 2023)
12100014 (Exp Jan 2023)
12100015 (Exp Jan 2023)
12100016 (Exp Jan 2023)
NDC:
10819-1080-1
10819-1080-2

Packaged as individual pouches in cartons or cases.

Product: Prevantics Swabstick (0.054 fl. Oz. / 1.6 mL)
Variants: 3.15% w/v chlorhexidine gluconate, 70% v/v isopropyl alcohol, 50 Individual Swabsticks per carton, 500 Individual Swabsticks per case
Model:
S40750
S32450
S42850
Lot Numbers:
12000203 (Exp Mar 2022)
12000204 (Exp Mar 2022)
12001114 LE (Exp Jun 2022)
12001115 LE (Exp Jul 2022)
12001117 LE (Exp Jul 2022)
12001313 (Exp Aug 2022)
12001407 (Exp Aug 2022)
12001408 (Exp Aug 2022)
12001498 (Exp Sep 2022)
12001499 (Exp Sep 2022)
12001500 (Exp Sep 2022)
12001629 (Exp Sep 2022)
12001630 (Exp Sep 2022)
12002070 (Exp Dec 2022)
12002114 (Exp Dec 2022)
12100106 (Exp Feb 2023)
12100107 (Exp Feb 2023)
12100223 (Exp Feb 2023)
12100224 (Exp Mar 2023)
12100225 (Exp Mar 2023)
12100354 (Exp Mar 2023)
12100513 (Exp Mar 2023)
12100514 (Exp Apr 2023)
12100515 (Exp Apr 2023)
12100605 (Exp Apr 2023)
12100628 (Exp Apr 2023)
12100629 (Exp May 2023)
12100630 (Exp May 2023)
12000332 (Exp Feb 2022)
12000484 (Exp Mar 2022)
12001116 LE (Exp Jul 2022)
12001312 (Exp Aug 2022)
12001730 (Exp Oct 2022)
12002071 (Exp Jan 2023)
12100105 (Exp Jan 2023)
12100222 (Exp Mar 2023)
12100635 (Exp Jun 2023)
12100636 (Exp Jun 2023)
12000728 (Exp Apr 2022)
12001119 LE (Exp Jul 2022)
12001631 (Exp Oct 2022)
12001811 (Exp Nov 2022)
12002115 (Exp Jan 2023)
12002116 (Exp Jan 2023)
12100221 (Exp Feb 2023)
12100633 (Exp May 2023)
12100634 (Exp Jun 2023)
12100774 (Exp Jun 2023)
12100817 (Exp Jun 2023)
NDC:
10819-4077-1
10819-4077-4
10819-4077-2
10819-4077-3

Packaged as individual pouches in cartons or cases.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89547
Status: Resolved
Manufacturer: Professional Disposables International, Inc.
Sold By: Medical supply distributors
Manufactured In: United States
Units Affected: 3 products (a) 9518 cases; b) 3347 cases; a) 160531 cases; b) 16123 cases; a) 28201 cases; b) 7579 cases; c) 8882 cases)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.