The Recall Desk
HighFDA (Devices)·Z-1068-2023·Announced 2023-02-15

Sterile Procedural Trays Recalled Due to Blade Package Puncture Risk

Medline sterile procedural trays are recalled because sterile blades within the kits can puncture the outer foil packaging, potentially compromising sterility. 622 cases (1,619 units) have been distributed worldwide.

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 an FDA Class II recall of sterile surgical procedural trays where blades within the kits can puncture the outer foil packaging. No illnesses or injuries have been reported. Per the rubric, risk-of-harm medical devices without reported illness score High (3).

Plain-English summary

Medline Industries is recalling multiple sterile procedural trays used in surgical and medical procedures. The affected products include 622 cases (1,619 units) of various surgical packs such as Port/Trach Insertion kits, Fistula packs, Vascular access packs, and others.

The sterile blades contained within these kits have the potential to puncture the outer foil layer of the sterile packaging. If the packaging is compromised, the sterility of the surgical instruments and supplies may be affected.

These products have been distributed worldwide, including to the United States, Canada, Japan, Mexico, Panama, Turks and Caicos, and the United Arab Emirates. Healthcare facilities that have received these trays should stop using them and contact Medline Industries for further instructions regarding return or replacement.

The recalled product

Product
Sterile Procedural Trays, labeled as the following: a. PORT/TRACH INSERTION CDS-3 b. RESIDENT DERM SURG PACK c. THROMBECTOMY PACK-LF d. AV FISTULA PACK e. AV SHUNT PACK-LF f. RR-VP SHUNT PACK-LF g. VEIN HARVESTING PACK-LF h. AV FISTULA PACK-LF i. PK, GEN-BARIATRIC j.
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical / Procedural Supplies
Hazard
  • package-puncture
  • sterility-compromise
  • 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 (20)

  • a. PORT/TRACH INSERTION CDS-3
  • Item Number: CDS983004D
  • Case UDI/GTIN: 40889942000464
  • Unit UDI/GTIN: 10889942000463
  • Lot Number: 22IBF922
  • 22IBE764
  • b. RESIDENT DERM SURG PACK
  • Item Number: DYNDA2997
  • Case UDI/GTIN: 40195327235353
  • Unit UDI/GTIN: 10195327235352
  • Lot Number: 22JBR611
  • c. THROMBECTOMY PACK-LF
  • Item Number: DYNJ0160348B
  • Case UDI/GTIN: 40889942211594
  • Unit UDI/GTIN: 10889942211593
  • Lot Number: 22IDB621
  • d. AV FISTULA PACK
  • Item Number: DYNJ01966N
  • Case UDI/GTIN: 40193489383769
  • Unit UDI/GTIN: 10193489383768

Distribution

Distributed nationwide across the United States.

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