Recall Z-2217-2019 ยท LFJ Catheter, Subclavian
Medical Components, Inc dba MedComp
14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061425 Product Usage: An aid for introducing a hemodialysis catheter
| Date | Mar 13, 2019 |
| Status | Terminated |
| Reason | Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer. |
| Root cause | Labeling Change Control |
| Action | On March 13, 2019, the firm notified customers via Urgent Medical Device Recall letter. Customers were informed that the kits contain a 15F "non-valved" peelable introducer despite the label indicating that the kit is packaged with a "valved" introducer. Customers were asked to do the following: 1. Immediately examine your inventory and quarantine product subject to recall. 2. If you have further distributed this product, please identify your customers and immediately notify them of the recall. 3. Contact your Medical Components, Inc. customer service representative for a Returned Goods Author |
| Quantity | 6830 |
| Distribution | US Nationwide Distribution CA FL GA IN KY LA MA MI MO MS NJ NY OH OK PA SC TN TX VA WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K893439 | HEMO-CATH SILICONE DOUBLE LUMEN CATH SL28C & SL40C Medical Components, Inc., Jun 13, 1989 |