MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101010
MEDLINE INDUSTRIES, LP - Northfield · It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their c…
Open FDA's page for this record- Cfres ID
- 207506
- Product res number
- Z-1937-2024
- Event date initiated
- 2024-04-22
- Event date posted
- 2024-05-31
- Recall status
- Open, Classified
- Res event number
- 94537
- Product code
- FMF
- Product description
- MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101010
- Code info
- UDI/DI 10884389596319, All lots in the format: 897YYMMXXXX
- Firm FEI number
- 1417592
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Address 1
- 3 Lakes Dr
- City
- Northfield
- State
- IL
- Postal code
- 60093-2753
- Additional info contact
- Karin Johnson 886-359-1704
- Root cause description
- Under Investigation by firm
- Product quantity
- 25,214,334 syringes
- Distribution pattern
- Worldwide distribution - US Nationwide and the countries of Canada, Panama, UAE, USVI.
- Reason for recall
It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their claimed graduated capacity and may pose a risk to patient health.
- Action
Medline Industries, LP, issued a recall notice to its consignees on 04/22/2024 via USPS first class mail. The notice explained the problem with the device, potential risk, and requested that the affected product be destroyed.
- K numbers
- K061275
- Harmonized identifiers (openFDA)
- Device name
- Syringe, Piston
- Medical specialty description
- General Hospital
- Regulation number
- 880.5860
- Device class
- 2
- K number
- K091377, K811167, K801311, K121124, K061275, K930321, K122023, K870192, K182279, K913235, K853450, K212207, K960882, K884921, K851089, K850958, K011176, K950666, K881980, K051720, K883744, K883094, K021993, K761158, K070264, K010890, K182274, K881791, K062365, K820294, K222744, K964597, K930791, K910520, K941020, K843473, K893862, K010708, K911440, K141762 +712 more
- Registration number
- 3004111573, 3006948745, 3005853033, 9681413, 3012944064, 3024088964, 3023174629, 1647137, 8031007, 3006788678, 3014315664, 1410248, 3014747754, 3014615644, 3014680149, 1450662, 3027500452, 9612152, 9611024, 3008650117, 3005941719, 3004054016, 3012461127, 3007084575, 3011504993, 1066491, 3025432964, 3009746061, 3008808123, 3016245399, 3013517171, 3006498370, 3005405146, 3030412764, 3007007790, 3043226252, 3019807891, 3003152976, 3011230048, 1825034 +511 more
- FEI number
- 1000268645, 3004111573, 3006948745, 3005853033, 3003056094, 3012944064, 3024088964, 3023174629, 1000306431, 3006788678, 3002808169, 3003857949, 3014315664, 1410248, 1000112877, 3014747754, 3014615644, 3014680149, 1450662, 3027500452, 3003640911, 3008650117, 3004054016, 3012461127, 3007084575, 3011504993, 3002808374, 3025432964, 3009746061, 3008808123, 3016245399, 3013517171, 3006498370, 3005405146, 3030412764, 3007007790, 3043226252, 3019807891, 3003152976, 3011230048 +511 more