Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI: (01)00630094430157
Recall
- Recall Number
- Z-1622-2021
- Event Number
- 87636
- Firm
- Bioseal Corporation
- FEI Number
- 2027062
- Product Code
- KDD
- Status
- Completed
- Root Cause
- Unknown/Undetermined by firm
- Initiated
- March 23, 2021
- Address
- 167 W Orangethorpe Ave, Placentia, CA, 92870-6922
Description
Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI: (01)00630094430157
Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a breach of the package integrity.
On 3/23/21, Bioseal emailed an "Urgent: Medical Device Recall" notice to affected consignees. In addition to informing consignees about the recall the firm ask consignees to take the following actions: 1. Please discontinue use of the product listed above. 2. Please complete enclosed response form listing the quantity of affected product on hand via email to [email protected]. Even if you do not have the affected product please complete and return the form. Once we have received the completed form we will forward product return information, if applicable. 3. If you have transferred possession of the product to another organization, you are required by FDA regulations to notify them of this recall communication. Please have any affected product returned to you for collection and return to Bioseal as specified above. 4. Adverse reactions or quality problems experience with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program. 5. If you have any questions regarding this matter, please contact customer service at 800-441-7325, Monday-Friday 8:00 AM - 5:00 PM P.S.T.
US: IL and MO OUS: None
1,560 units