The Recall Desk
HighFDA (Devices)·Z-0161-2023·Announced 2022-11-09

Surgical Cataract Packs with Compromised Breather Pouch Seals Recalled

Medline recalls 708 Bausch + Lomb cataract surgical packs due to breather pouch seal defects that could compromise sterility of surgical instruments.

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 for a medical device with potential to compromise sterility in surgical kits. No reported illnesses or injuries documented; the hazard is theoretical based on the risk posed by seal defects.

Plain-English summary

Medline Industries has recalled 708 units of the Bausch + Lomb Cataract Pack (Reference VAL001CPMEA, Lot 22DBL466) used in surgical procedures.

The recall was initiated after the company received complaints that breather pouches within the sterile surgical kits had openings in their seals. Compromised seal integrity can allow contamination and affect the sterility of the surgical instruments and materials inside the kit.

The affected kits were distributed nationwide to surgical facilities in California, Minnesota, North Carolina, New York, Oklahoma, Pennsylvania, Tennessee, and Texas.

If you have received this product, do not use the affected kits. Contact Medline Industries for instructions on return or replacement.

The recalled product

Product
BAUSCH + LOMB CATARACT PACK, REF VAL001CPMEA. Convenience kit used in surgical procedures.
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Kits
Hazard
  • seal-compromise
  • 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) 10195327108168
  • Lot Number 22DBL466

Distribution

Distributed nationwide across the United States.

Related recalls

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