Medline Dental Pack Recall Due to Breather Pouch Seal Defect
Medline is recalling Dental Pack surgical kits (Lot 22DBE139) because breather pouches have openings in their seals that could compromise sterility. Affected units were distributed to healthcare facilities in eight US states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with potential for sterility compromise due to seal defects in surgical kit packaging. No illnesses or injuries reported in the source text; the hazard remains theoretical.
Plain-English summary
Medline Industries is recalling Medline Dental Pack surgical kits (Reference DYNJ66983, Lot Number 22DBE139) after receiving complaints that breather pouches within the sterile kits show openings in their seals.
The openings in the breather pouch seals could allow the sterile surgical kits to become contaminated. This defect poses a potential risk to patients and healthcare workers who rely on the sterility of these surgical kits for medical procedures.
The recall affects 60 units that were distributed nationwide to healthcare facilities in California, Minnesota, North Carolina, New York, Oklahoma, Pennsylvania, Tennessee, and Texas.
Healthcare facilities that have received these kits should cease use immediately. Contact Medline Industries for further information about the recall.
The recalled product
- Product
- MEDLINE DENTAL PACK, REF DYNJ66983. Convenience kit used in medical procedures.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical kits
- Hazard
- packaging-defect
- sterility-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- GTIN (01) 40193489385404
- Lot Number 22DBE139
Distribution
Distributed nationwide across the United States.
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