MedComp Recalls Hemodialysis Catheters and PICCs Due to Sterilization Error
Medical Components, Inc dba MedComp is recalling 243 hemodialysis catheters and PICCs because a duplicate sterilization process may have rendered included drug products ineffective.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves a risk-of-harm product where the sterilization error may render drug products ineffective, but the source explicitly states that no injuries or illnesses have been reported.
Plain-English summary
Medical Components, Inc dba MedComp is recalling 243 units of hemodialysis catheters and peripherally inserted central catheters (PICCs). The affected products include specific models such as the SF X 24CM LT HEMO-CATH and various Pro-PICC trays. These devices are intended for long-term vascular access for hemodialysis, apheresis, and intravenous therapy.
The recall was initiated because the 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 items: 5ml ampule of lidocaine, 3ml Chloraprep one-step, 10ml pre-filled saline syringe, Hygea saline wipes, and 3ml tinted Chloraprep. The affected lot numbers are MBWK970, MBWH890, MBWJ180, MBWJ460, MBWH910, and MBWH940.
The products were distributed nationwide in the United States. No injuries or illnesses have been reported in connection with this recall. Consumers and healthcare providers should stop using these products and contact the manufacturer for further instructions.
The recalled product
- Product
- Hemodialysis Catheters and PICCs: Product identification: MCDLTSL24P (SF X 24CM LT HEMO-CATH), MC061422 (14FX15CM SLX DBL LMN ST CATH), MRCTP41017 (4F X 55CM SINGLE CT PICC), MRCTP52007 (5F DUAL PRO-PICC NURSING TRAY), MRCTP52010 (5F DUAL PRO-PICC MAX BARR TRAY)…
- Manufacturer
- Medical Components, Inc dba MedComp
- Category
- Medical Device — Catheters
- Affected units
- 243
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 (6)
- Lot numbers: MBWK970
- MBWH890
- MBWJ180
- MBWJ460
- MBWH910
- MBWH940
Distribution
Distributed nationwide across the United States.
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