Recall Z-1622-2021 ยท KDD Kit, Surgical Instrument, Disposable
Bioseal Corporation
Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI: (01)00630094430157
| Date | Mar 23, 2021 |
| Status | Completed |
| Reason | 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. |
| Root cause | Unknown/Undetermined by firm |
| Action | 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 recalls@biosealnet.com. 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 |
| Quantity | 1,560 units |
| Distribution | US: IL and MO OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.