FDA Device recall Z-2421-2014
UNIVERSAL PACK - (1) UTILITY BOWL 16oz. (1) NEEDLE SPINAL ANEST. 22G X 31!2 (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK LIF (2) SYRINGE 10ccWI…
- FDA Device
- Class I
- terminated
- Published 2014-09-10
On 2014-09-10 the FDA classified a Class I recall of UNIVERSAL PACK - (1) UTILITY BOWL 16oz. (1) NEEDLE SPINAL ANEST. 22G X 31!2 (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK LIF (2) SYRINGE 10ccWI… by Customed, citing customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2421-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-05-20 |
| Published | 2014-09-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Customed |
| Distribution | US |
Product
UNIVERSAL PACK - (1) UTILITY BOWL 16oz. (1) NEEDLE SPINAL ANEST. 22G X 31!2 (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK LIF (2) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK LIF (1) NEEDLE HYPODERMIC 20G X 1 1!2 (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMIIII (1) SPLIT SHEET WITH ADHESIVE 108" X 77" SMS STD LIF (1) DRAPE % ECONOMY 53" X 77" UF (2) TOWEL ABSORBENT 15" X 20" UF (4) DRAPE UTILITY WITH TAPE LIF (1 0) GAUZE SPONGES 4" X 4" 12PL Y (4) TOWELS CLOTH HUCK BLUE (1) TABLE COVER REINFORCED 50" X 90" UF (1) SCALPEL WITH HANDLE #11 (3) PK. CLOSURE SKIN W' X 4" STERI STRIP UF (1) SKIN MARKER WITH RULER (1) DENTURE CUP 8oz WITH LID (1) NEEDLE HYPODERMIC 25 X 1 1!2 (1) STOCKINETTE IMPERVIOUS 14" X 48" (2) TIP ABSORB. APPLICATOR STICK SPONGE (1) TRAY ORGANIZER FULL DEEP (1) TRA 2/COMPARTMENT (1) RULER L/F Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Reason
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
Identifiers
| code_info | Product code 900-1936, 22 lots: 110082088 110082207 110102439 110112627 110112928 111010082 111030630 11104110…Product code 900-1936, 22 lots: 110082088 110082207 110102439 110112627 110112928 111010082 111030630 111041100 111051372 111061520 111071785 111113056 111123422 112010103 112041214 112062469 112083415 113109769 131210637 140111090 140312098 140412891 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2421-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.