14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422
Reported: April 24, 2019 Initiated: March 13, 2019 #Z-1149-2019
Product Description
14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422
Reason for Recall
Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
Details
- Recalling Firm
- Medical Components, Inc dba MedComp
- Units Affected
- 6830
- Distribution
- Distributed to accounts in CA FL GA IN KY LA MA MI MO MS NJ NY OH OK PA SC TN TX VA WV.
- Location
- Harleysville, PA
Frequently Asked Questions
What product was recalled? ▼
14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422. Recalled by Medical Components, Inc dba MedComp. Units affected: 6830.
Why was this product recalled? ▼
Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 24, 2019. Severity: Moderate. Recall number: Z-1149-2019.
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