MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM";
Aesculap Inc · Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issu…
Open FDA's page for this record- Cfres ID
- 205444
- Product res number
- Z-0866-2024
- Event date initiated
- 2023-12-29
- Event date posted
- 2024-01-31
- Recall status
- Open, Classified
- Res event number
- 93793
- Product code
- HCF
- Product description
- MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM";
- Code info
- UDI-DI 4046955075546 Firm did not identify affected lots or expiration date. Affected product was distributed between November 23, 2022 and October 13, 2023.
- Firm FEI number
- 2916714
- Recalling firm
- Aesculap Inc
- Address 1
- 3773 Corporate Pkwy
- City
- Center Valley
- State
- PA
- Postal code
- 18034-8217
- Additional info contact
- Quality Assurance 833-425-1464
- Root cause description
- Nonconforming Material/Component
- Product quantity
- 53
- Distribution pattern
- US Nationwide distribution in the states of CA, CO, FL, ID, KY, MD, MO, MT, NV, NY, OR, PA, RI, TN, TX, VA.
- Reason for recall
Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue may lead to a short delay in procedure.
- Action
On December 29, 2023, the firm notified affected customers via URGENT MEDICAL DEVICE RECALL NOTIFICATION letters. Customers were instructed to cease use and quarantine all product subject to recall. Once Aesculap Customer Support receives the customer's acknowledgement form, they will contact the customer to arrange for credit and to have the current inventory returned.
- Harmonized identifiers (openFDA)
- Device name
- Instrument, Ligature Passing And Knot Tying
- Medical specialty description
- General, Plastic Surgery
- Regulation number
- 878.4800
- Device class
- 1
- K number
- K150882, K841617, K851452, K790577, K931379
- Registration number
- 1058726, 1835444, 3010687973, 8044098, 8043548, 3012507533, 3030516433, 9616250, 3004450679, 3020954746, 3006591312, 1421879, 3003431869, 1219930, 1218017, 3011600579, 9612278, 1056350, 3013756169, 2080222, 3015976667, 2431166, 1055236, 3007648354, 3007589150, 1211566, 3003807268, 1836161, 3009142291, 3007773213, 1450662, 3006154292, 8040278, 2528981, 3021519357, 3035708926, 9610612, 1820334, 1422634, 3004464325 +127 more
- FEI number
- 3002299608, 3942, 3010687973, 3012507533, 3030516433, 3004450679, 3020954746, 3006591312, 3003431869, 1219930, 1218017, 3011600579, 1000514656, 1000140363, 3013756169, 3003040625, 2080222, 3015976667, 3004595684, 3004216008, 3007648354, 3007589150, 1000112877, 3009504761, 1211566, 3003807268, 3009142291, 3002929183, 3002806816, 3002807798, 3007773213, 1000160162, 1450662, 3000280067, 1000115048, 3006154292, 2528981, 3002808001, 3021519357, 3035708926 +127 more