Arrow Sheath Introducers Recall
Jul 26, 1994 | www.fda.gov
Arrow Percutaneous Sheath Introducer Kits with Polyurethane Sheath:
(a) Product No. AKO9801S;
(b) Product No. AK09810S;
(c) Product No. AK09810C;
(d) Product No. BD09880;
(e) Product No. CK01000;
(f) Product No. DS09850S;
(g) Product No. IC09880;
(h) Product No. MH09800;
(i) Product No. H09810VKS;
(j) Product No. NR09810S;
(k) Product No. PS09810S;
(l) Product No. S109880SE;
(m) Product No. SJ09805;
(n) Product No. SV09804;
(o) Product No. UT09880;
(p) Product No. WB09810S;
(q) Product No. CK01410;
(r) Product No. AK09817S;
(s) Product No. CA09886;
(t) Product No. LJ09807S;
(u) Product No. PH09806.
Recall #Z-051/071-5.
CODE Lot numbers:
(a) AK91084, AK91404;
(b) AK91574, AK90944, AK91294;
(c) AK90524; (d) B0664, B0664A;
(e) C1574; (f) D0384; (g) I1124;
(h) H1004, MH09800; (i) M1004;
(j) NR0874, NR1294; (k) S1364; (l) I1224;
(m) S1784; (n) S2913; (o) T1014, T1014A;
(p) W1924; (q) C1784Z; (r) AK90804;
(s) C0604; (t) L1574; (u) P1294.
MANUFACTURER:
Arrow International, Inc., Randleman, North Carolina.
RECALLED BY:
Arrow International, Inc., Reading, Pennsylvania, by telephone beginning July 26, 1994, followed by letter July 28, 1994. Firm-initiated recall ongoing.
DISTRIBUTION: Nationwide, Puerto Rico, Canada, Australia, Holland, Japan, United Kingdom.
QUANTITY: 20,905 units were distributed.
REASON:
A process change, file number REV-3958, was initiated to reduce the amount of scrap from shrinkage of the hub. This process change was not validated. Inadequate luer lock connections between the sheath and hemostasis valve can result in bleeding or air embolisms to occur.
