Hemodialysis Catheters and PICCs: Product identification: MCDLTSL24P (SF X 24CM LT HEMO-CATH), MC061422 (14FX15CM SLX DB
FDA device recall Z-1083-2015 · posted 2015-02-10 · Terminated
Recall details
- Recalling firm
- Medical Components, Inc dba MedComp
- Reason for recall
- Drug products contained within the kits may have been rendered ineffective by a duplicate sterilization process. The kits include one or more of the following drugs: 5ml ampule of lidocaine, 3ml Chloraprep one-step, 10ml pre-filled saline syringe, Hygea saline wipes, and 3ml tinted Chloraprep. No injuries or illnesses were reported.
- Action taken
- Medcomp sent a Product Alert/Recall letter dated January 21, 2015 to customers via email. The letter identified the affected product, problem and actions to be taken. Medcomp requested the return of all affected product. Customers were instructed to contact their customer service representative for instructions for returning the product.
- Root cause
- Process control
- Status
- Terminated
- Product code
- LFJ
- Quantity affected
- 243
- Distribution
- US Nationwide Distribution
- Date initiated
- 2015-01-21
- Date posted
- 2015-02-10
- Date terminated
- 2015-08-03
- Location
- Harleysville, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEMO-CATH SILICONE DOUBLE LUMEN CATH SL28C & SL40C (K893439) | Medical Components, Inc. | 1989-06-13 |
| HEMO-CATH SILICONE DOUBLE LUMEN CATHETER (K890029) | Medical Components, Inc. | 1989-04-17 |