MEDLINE Surgical Kits Recalled Due to Defective SafeAir Component
Medline is recalling 3,452 units of surgical convenience kits nationwide due to a defective SafeAir Smoke Evacuation Pencil component previously recalled by Stryker. No illnesses or injuries have been reported.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II FDA medical device recall with no reported illnesses or injuries. The recall is precautionary in nature, triggered by a supplier component previously recalled by its manufacturer, and does not indicate an identified hazard in the MEDLINE kits themselves.
Plain-English summary
Medline Industries, LP is recalling 3,452 units of surgical convenience kits distributed nationwide. The kits contain the SafeAir Smoke Evacuation Pencil, a surgical component that was previously recalled by its manufacturer, Stryker.
The recalled kits include various models designed for gynecological and abdominal surgical procedures, including hysterectomy packs, laparoscopic procedure kits, and vaginal surgery convenience kits. Forty-four different kit models with multiple lot numbers are affected.
No illnesses or injuries have been reported in connection with this recall. Healthcare facilities and consumers in possession of these kits should discontinue use and contact Medline for information on return or replacement options.
The recalled product
- Product
- MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G; 2) LAVH CDS, REF CDS983411J; 3) MAJOR VAGINAL, REF CDS983497L; 4) DAY SURG LARGE VAG CDS, REF CDS984995N; 5) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 6) D&C/HYSTEROSCOPY PACK, REF
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- surgical-tool-defect
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)
- 85OJF 1) REF CDS760056G
- UDI/DI 10195327009656 (each) 40195327009657 (case)
- Lot Numbers: 24BBQ489
- 23KBP697
- 2) REF CDS983411J
- UDI/DI 10195327150273 (each) 40195327150274 (case)
- Lot Numbers: 22LDA249
- 23CDB670
- 23JDA480
- 23IDA660
- 3) REF CDS983497L
- UDI/DI 10195327560980 (each) 40195327560981 (case)
- Lot Numbers: 24ADA431
- 24BDB524
- 4) REF CDS984995N
- UDI/DI 10195327587963 (each) 40195327587964 (case)
- Lot Numbers: 24GBH834
- 24EBL666
- 24ABA667
- 24DBI833
Distribution
Distributed nationwide across the United States.
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