Surgical Kit Sterile Pouches with Seal Openings Recalled by Medline
Medline is recalling approximately 160 surgical kits with defective breather pouches showing seal openings, potentially compromising sterility. The recall affects facilities in eight states nationwide.
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: This is a Class II medical device recall with no reported illnesses or injuries, but involves seal defects in sterile surgical kits that create a theoretical risk of contamination. Per the severity rubric, this qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medline Industries is recalling BAUSCH + LOMB PHACO surgical kits (reference number LYN011PHNHD, lot 22DBM505) after receiving complaints about seal defects in the breather pouches. Some breather pouches within these sterile surgical kits show openings in the seal.
Approximately 160 kits were affected by this recall. The defective kits were distributed nationwide to healthcare facilities in California, Minnesota, North Carolina, New York, Oklahoma, Pennsylvania, Tennessee, and Texas.
The openings in the breather pouch seals compromise the sterility barrier of the surgical kit contents, potentially allowing contamination to enter the package. This defect creates a risk of contamination during surgical procedures in which these kits are used.
The recalled product
- Product
- BAUSCH + LOMB PHACO PACK, REF LYN011PHNHD. Convenience kit used in surgical procedures.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- seal-breach
- contamination-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) 40193489234405
- Lot Number 22DBM505
Distribution
Distributed nationwide across the United States.
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